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ORIGINAL RESEARCH COMMUNICATION |
1 From the Program in International and Community Nutrition, University of California, Davis, CA (SA-A, KHB, and KGD); the Department of Nutrition and Food Science, University of Ghana, Legon, Ghana (AL); the Hospital for Sick Children, University of Toronto, Toronto, Canada (SZ); and IRD, Département Sociétés et Santé, Paris, France (AB)
2 The opinions expressed herein are those of the authors and do not necessarily represent the views of ILSI or USAID. 3 Supported by the Nestlé Foundation and the MGL Research Program (USAID) through the Human Nutrition Institute of the International Life Sciences Institute (ILSI). 4 Reprints not available. Address correspondence to KG Dewey, Department of Nutrition, University of California, One Shields Avenue, Davis, CA 95616-8669. E-mail: kgdewey{at}ucdavis.edu.
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Objective: The objective was to compare the efficacy and acceptability of Sprinkles (SP), crushable Nutritabs (NT), and fat-based Nutributter (NB; 108 kcal/d), which provide 6, 16, and 19 vitamins and minerals, respectively, when used for home fortification of complementary foods.
Design: Ghanaian infants were randomly assigned to receive SP (n = 105), NT (n = 105), or NB (n = 103) daily from 6 to 12 mo of age. We assessed dietary intake, morbidity, and compliance weekly. Hemoglobin and plasma ferritin, TfR, C-reactive protein, and zinc were measured at 6 and 12 mo. We used an exit interview to assess acceptability. A randomly selected control group of infants who received no intervention (NI; n = 96) were assessed at 12 mo.
Results: All supplements were well accepted, and the mean percentage of days that supplements were consumed (87%) did not differ between groups. At 12 mo, all 3 intervention groups had significantly higher ferritin and lower TfR concentrations than did the NI control group. Mean (± SD) hemoglobin was significantly higher in NT (112 ± 14 g/L) and NB (114 ± 14 g/L) but not in SP (110 ± 14 g/L) infants than in NI infants (106 ± 14 g/L). The prevalence of iron deficiency anemia was 31% in the NI control group compared with 10% in the intervention groups combined (P < 0.0001).
Conclusion: All 3 options for home fortification of complementary foods are effective for reducing the prevalence of iron deficiency in such populations.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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400 km north of Accra, nearly 30% of infants 6 mo of age had a hemoglobin concentration <100 g/L (2). Because multiple micronutrient deficiencies often coexist and stunting is prevalent in Ghana, it is likely that Zn deficiency is also common among Ghanaian infants. The deleterious effects of iron deficiency on cognitive development in infants are well documented, whereas zinc deficiency has been implicated in growth faltering (3) and increased morbidity, particularly diarrheal disease and pneumonia (4). Because it may not be possible to reverse the adverse effects on cognitive development, optimal approaches for prevention are needed. Home fortification of complementary foods with Sprinkles (SP; 5), a crushable tablet (such as the Foodlet; 6), or a lipid-based nutrient supplement (a more concentrated version of Ready-to-Use Therapeutic Food) has several advantages: it does not require major changes in dietary practices, allows the child to obtain a full dose of micronutrients when mixed with a small quantity of food, is better accepted than medicinal iron drops taken between meals, and is less expensive than centrally processed, fortified complementary foods. Evidence in support of the efficacy of home fortification is building. In Cambodia, SP added to home-prepared complementary foods increased the hemoglobin concentration of infants from 6 to 18 mo of age (7). Similar results were found for Foodlet when added to complementary foods for infants in South Africa (8). In Malawi, undernourished infants 6–17 mo of age consuming modified Ready-to-Use Therapeutic Food had a significantly greater hemoglobin concentration than did those who received no supplement (9). Although SP can deliver several micronutrients at the same time, there is a limit to the number and amounts of nutrients that can be incorporated in its formulation, compared with Foodlet or the lipid-based nutrient supplements. Whereas lipid-based supplements provide some energy, essential fatty acids, and protein, the SP and Foodlet supplements do not.
The present study was part of a randomized trial to compare the ability of SP, a modified Foodlet (herein referred to as Nutritabs; NT), and a lipid-based nutrient supplement (herein referred to as Nutributter; NB) to improve the growth and micronutrient status of Ghanaian infants aged 6–12 mo when added to home-prepared complementary foods. We also assessed acceptability, morbidity, and motor milestone acquisition. We reported previously that infants in the NB group had significantly greater weight gain and linear growth than did those in the SP and NT groups (combined), and that all 3 supplements increased the odds of being able to walk independently by 12 mo of age when compared with a nonintervention (NI) control group (10). The objective of this study was to compare the effects of these 3 supplements on iron and zinc status and the acceptability of the supplements among infants and their mothers. These results are relevant to the use of these 3 supplements for anemia control and other nutrition programs for infants and young children in developing countries.
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SUBJECTS AND METHODS |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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87 000; annual rainfall averages 2030 mm. The principal complementary food in most households is a fermented maize-based porridge. All infants attending weight-monitoring sessions in Koforidua between February and September 2004 were potentially eligible. Children who were 5 mo of age and receiving breastmilk (whether or not exclusively) were considered eligible; those who were known to be asthmatic or allergic to peanuts or whose parents were planning to leave the study site during the next 7 mo were excluded. The Human Subjects Review Committee of the University of California Davis and the Institutional Review Board of the Noguchi Memorial Institute for Medical Research, University of Ghana, approved the study protocol. The Eastern Regional Health Administration gave written permission to carry out the study in Koforidua, and we obtained written informed consent from the parents of each infant.
Study design
We designed the study as a community-based randomized trial involving 3 intervention groups and one Non-intervention (NI) group (total 4 groups). Because of logistical constraints, we could not include all infants who were eligible each week in the intervention groups. Therefore, we randomly selected 75% of the total number of eligible infants to enter the intervention trial. This was done on a weekly basis, when infants were 5 mo of age, by entering the identification numbers of the eligible infants in a dataset, and using an SAS data step (ranuni [1] le 0.75) to select those for the intervention. We began collecting weekly morbidity data starting at 5 mo of age for infants whose parents gave consent. At 6 mo, the intervention infants were randomly assigned (using opaque envelopes with group designations) to receive SP, NB, or NB until 12 mo of age.
The NI control infants were enrolled at 12 mo of age from among the 25% of those who were originally eligible but not selected for the intervention groups (n = 170). We could not administer a placebo because of ethical concerns about providing no treatment to infants who may have tested low on certain assessments (eg, hemoglobin) at 6 mo of age; therefore, we included the NI control group for assessment at 12 mo of age as an alternative. For this reason, it was not possible to collect data for this control group at 6 mo. However, because the NI infants were randomly selected from the pool of initially eligible infants, they should have been similar to the other 3 groups initially.
Sample size
Because there were several primary outcomes (micronutrient status and growth), our strategy was to calculate the sample size based on detecting, for any outcome considered, differences between the 4 groups equivalent to or greater than Cohen's (1988) "medium" effect size of 0.5, ie, (difference/pooled SD) = Cohen's d = 0.5 (11). This effect size indicates that there would be 
33% nonoverlap between the distribution of values for any 2 groups being compared (11). An effect size of 0.5 would represent a difference of 7 g/L in hemoglobin, 17.5 µg/L in plasma ferritin, 2.1 mg/L in plasma TfR (TfR), and 1.2 µmol/L in plasma zinc, based on our observed SDs. With 0.05 
and 80% power, the required sample size per group was 87. Allowing for 15% attrition in the 3 intervention groups, the target sample size for each of those groups was 102. At 12 mo, to achieve the target sample size of 87 for the NI control group, we randomly selected 130 of the 170 eligible children, assuming that some of the parents would have moved away or decline to participate in the study.
Micronutrient supplements
The nutrient composition of the 3 supplements is reported in Table 1
. SP was manufactured by Ped-Med Inc, Canada, in single sachets (dose = 1 sachet/d). NT (1 tablet/d) was manufactured by Laboratoires Pharmaceutiques Rodael SA (Bierne, France) and supplied by Nutriset SA, which also manufactured the NB. NT was provided to the mothers in plastic bags, and the NB (20 g/d) was provided in foil packs equipped with screw caps (net weight = 200 g). NT and NB were designed so that the daily dose would generally provide the needed amounts from complementary foods for all of the key nutrients (12, 13). Because of technical difficulties associated with adding the desired amounts of the 4 macro-minerals (calcium, potassium, magnesium, and phosphorous), we included as much calcium, potassium, and phosphorous as possible in both supplements and maintained the amounts of magnesium (and manganese) already contributed by the ingredients of the NB. Because of logistical problems at the start of the study, we had to use SP from a batch that was available at the time, which had slightly higher amounts of iron and zinc (and different chemical compositions of these 2 minerals) than contained in NT and NB. Similar types of SP have been used in Cambodia (7), and the doses were consistent with recommended daily intakes.
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Data and blood sample collection
Using pretested questionnaires, fieldworkers collected background and socioeconomic status data at home at the time of recruitment (at 5 mo for the intervention groups and at 12 mo for the NI control group). We recorded the infants' birth dates and weights from Immunization and Weighing Cards.
Fieldworkers visited the homes of the intervention children weekly to collect morbidity data from 5 to 12 mo and information on food intake and supplement consumption from 6 to 12 mo. Leftover supplements were collected and recorded each week. A fieldworker who had previously been trained for the World Health Organization Multicenter Growth Reference Study completed naked weight, recumbent length, and head circumference measurements at 6, 9, and 12 mo and assessed 4 gross motor milestones (standing with assistance, walking with assistance, standing independently, and walking independently) at 12 mo using protocols described for the Multicenter Growth Reference Study (14, 15). We collected venous blood samples (using heparin-treated, trace element–free tubes) at 6 and 12 mo while the intervention children were still receiving the supplements. Blood samples (nonfasting) were collected in the morning and immediately placed on ice. Plasma was separated within 1 h by centrifugation at 1750 x g for 10 min at room temperature and divided into aliquots that were stored frozen at –40 °C until further analyzed. Blood smears were prepared for malaria screening. The anthropometrist also measured the mother's weight using an electronic weighing scale (SECA 770; Seca, Hamburg, Germany) and height by using a standing height measurement microtoise at the time that her child was measured at 6 mo.
For the NI control children, data on morbidity and food intake were collected at the time of recruitment at 12 mo, for the week before the interview. Immediately after recruitment, anthropometric measurements were performed (including those of mothers), gross motor milestones were assessed, and venous blood samples were collected, as was done for the intervention children.
Assessment of supplement acceptability
We used an exit interview at the end of supplementation (ie, at 12 mo) to assess each mother's (and her child's) attitudes toward the supplement (such as size or quantity of the daily amount of supplement used, ease of use, children's acceptance of food mixed with the supplement, and overall acceptability) and to ask about possible future use of the supplement. The questionnaire for this assessment, which was pretested before the study and administered at home to mothers by their previously assigned fieldworkers, was developed on the basis of our previous knowledge of the characteristics of mothers and complementary feeding behavior at the study area and some of the practical issues that are likely to arise from using (or wanting to use) the supplements in low-income populations. For most questions, we provided 3 options for response, which reflected a positive, neutral, or negative reaction. In addition, we gave mothers the chance to explain or comment on the responses they gave. Using 3 estimates (US $0.03/d, 0.05/d, and 0.08/d) of what the local cost of the supplement might be if produced large scale (and assuming local ingredients as the basis for NB), we asked mothers if they would purchase the product at each price. Finally, we asked mothers if they sometimes administered the recommended dose without mixing it with any food, juice, or water; by mixing it with foods or juices other than cereal porridge; by mixing it with water; or by giving it in small doses 2–3 times during the day.
Biochemical measurements
We measured hemoglobin and plasma ferritin, TfR, and C-reactive protein (CRP) for all children for whom a blood sample was available. Hemoglobin was measured by using the Hemocue instrument (Hemocue Inc, Mission Viejo, CA) within 3 min of drawing blood. Ferritin was analyzed by the Coat-A-Count Immunoradiometric assay kit (Diagnostic Products Corporation, Los Angeles, CA), TfR was analyzed by enzyme-linked immunosorbent assay (Ramco Laboratories Inc, Stafford, CT), and CRP, an index of concurrent infection, by radial immunodiffusion (The Binding Site Inc, San Diego, CA). Because of the difficulty of drawing blood from some children, we determined plasma zinc in a subsample of children in each group for whom we had enough plasma for all the other intended biochemical assays (n = 55–69 per group) by using inductively coupled plasma mass spectrometry (16) at the Children's Hospital Oakland Research Institute, Oakland, CA. We calculated that a minimum sample size of 50 per group for comparing 4 treatment groups (SigmaStat; Systat Software, Richmond, CA) would give 80% power for detecting a mean difference in plasma zinc of 1 µmol/L, with 0.05 , assuming a SD of 1.5 µmol/L (from a set of 38 previously analyzed samples).
Malarial screening
At each blood draw, we screened all children for malarial parasites by staining blood smears with 2% Giemsa stain in phosphate-buffered saline and examining the smear under a microscope at 1000x magnification (17).
Statistical analysis
Data were analyzed by using SAS version 8.1 (SAS Institute, Inc, Cary, NC). Background demographic and socioeconomic differences between all 4 groups and blood indexes between the 3 intervention groups at 6 mo were analyzed by using analysis of variance or a chi-square test. Because we did not collect direct information on household income and expenditure, we created 2 household "wealth factors" from a set of 14 socioeconomic status variables using factor analysis with varimax rotation as proxy indicators for household economic status (18). We used the first factor to create an index ("amenities factor") to represent household amenities, such as type and location of toilet facility, and the second factor to create an index ("electronic items factor") to represent ownership of electronic items, such as television and radiocassette. Low values of these factors indicated poor households, and high values indicated wealthy households. Adherence to treatment was determined as the percentage of scheduled days on which the supplement was reportedly added to the child's food, and the median adherence with 95% CI was calculated by bootstrapping (19).
Analysis of outcome data were based on intention-to-treat, ie, regardless of adherence to treatment. Because we based our sample size on the detection of differences between 4 groups, our aim was to compare all 4 groups at 12 mo. However, because we had no baseline biochemical data for the NI control children at 6 mo, differences in hemoglobin (g/L) and plasma TfR (mg/L), ferritin (µg/L) and zinc (µmol/L) (with Tukey adjustment for pairwise comparisons) at 12 mo were assessed twice, first among the 3 intervention groups with control for the 6-mo values and sex (because of baseline differences) and then among all 4 groups with control for sex only by using analysis of covariance. We natural log transformed ferritin and TfR values before analysis. Prevalence of low (<100 g/L) hemoglobin (20), low (<5 and < 12 µg/L) ferritin (2, 20), high (>11 mg/L) TfR (20), iron deficiency anemia (hemoglobin < 100 g/L with ferritin < 12 µg/L or TfR > 11 mg/L) (2, 20), low (<9.9 µmol/L) plasma zinc (21), positive malaria smear, and elevated (>11 mg/L) CRP concentration among intervention groups at 6 mo, and among all groups at 12 mo, were compared by using chi-square tests. For low ferritin, we used 2 cutoff points, <12 µg/L and < 5 µg/L, first to be consistent with our previous study in Ghana (2), in which we used the <12 µg/L cutoff, and second, because of a recent study showing that a lower cutoff point of <5 µg/L may be more appropriate for infants 9 mo of age (20). Changes in anemia prevalence within intervention groups from 6 to 12 mo were analyzed by using McNemar's chi square. We calculated the odds of being anemic and of having iron deficiency anemia at 12 mo for the intervention groups by using multiple logistic regression with adjustment for child sex and with the NI control group serving as the reference category. Subjects (15 of 261 at 6 mo and 28 of 351 at 12 mo) with a CRP concentration >11 mg/L were excluded from all analyses that included ferritin. We used a CRP cutoff point of 11 mg/L, rather than 8 (2) or 10 (22) mg/L, because the kit used a cutoff of 11 mg/L corresponding to a clear demarcation (5.0-mm ring diameter) on the measuring device. We analyzed the indices of supplement acceptability by using chi-squared tests, and compared mean values for how much mothers in each group said they were willing to pay for a week's supply of the supplement by using ANOVA. In all analyses, we used a significance level of 0.05.
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RESULTS |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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). Parents of 44 infants (10%) declined participation, 30 infants (7%) were unable to participate because of the time constraints of their parents, and we could not locate the homes of 55 infants (12%). The remaining 313 attended the blood sampling at 6 mo and at that time were randomly assigned into 1 of the 3 intervention groups. Of these, 15 infants moved away from the study area (SP: n = 7; NT: n = 3; NB: n = 5), and 298 completed the study.
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Subject characteristics and adherence to treatment
The 3 intervention groups did not differ significantly in baseline characteristics (Table 2), hemoglobin, iron status, or plasma zinc (Table 3), except for the fact that there were significantly more males in the NB group (61%) compared with the other 2 groups (SP: 48%; NT: 43%), and the NT group had a significantly lower mean weight, and consequently, a lower mean weight-for-age and weight-for-length than did the SP and NB groups. The subsample of children with sufficient plasma for the zinc assessments did not differ significantly in sex or background socioeconomic and demographic characteristics from those without sufficient plasma for these assessments (data not shown). In comparisons that included all 4 groups, there were no significant differences in characteristics, except for the abovementioned sex difference. At 12 mo, median adherence (95% CI) to treatment did not differ significantly between intervention groups [SP: 85.8 (82.3, 90.0); NT: 87.5 (84.8, 90.3), and NB: 88.2 (86.1, 92.3).
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), there were no significant differences between the 3 intervention groups (3-group comparison) in mean hemoglobin, plasma zinc, or geometric mean plasma ferritin or TfR concentrations. When all 4 groups were compared, the NT and NB groups, but not the SP group, had significantly greater mean hemoglobin than did the NI control group. All 3 intervention groups had a significantly lower mean TfR concentration and greater ferritin concentration than did the NI control group. There were no significant differences in mean plasma zinc concentrations between groups, and control for the CRP concentration (elevated compared with not elevated) and time of day when blood was collected did not alter these results.
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) to 10–18% at 12 mo (Table 5). The prevalence of low ferritin (using the cutoff point of either 5 or 12 µg/L) and high TfR did not change significantly in any of the intervention groups, whereas the prevalence of iron deficiency anemia decreased significantly in the NT group, but not in the SP or NB groups. At 12 mo, there were no significant differences in the prevalence of anemia, iron deficiency, or iron deficiency anemia between the 3 intervention groups. In the NI control group, 32% of the infants were anemic, compared with 15% for the intervention infants as a whole (P = 0.0008); 45% had high TfR, compared with 20% for the combined intervention groups (P < 0.0001); 54% had low ferritin (using the ferritin cutoff of 12 µg/L), compared with 26% of the intervention infants (P < 0.0001); and 31% had iron deficiency anemia, compared with 10% in the intervention groups combined (P < 0.0001). Using the NI control group as the reference, the odds of being anemic or having iron deficiency anemia at 12 mo were significantly lower in all 3 intervention groups (Table 5). These odds remained virtually unchanged and significant after adjustment for child's sex. There were no significant differences between groups in the percentage of infants with plasma zinc <9.9 µmol/L.
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) or 12 mo (all 4 groups: range 2.0–8.3%; Table 5). Similarly, the groups did not differ in the percentage of children with elevated CRP at either 6 mo (range: 3.4–10.7%) or 12 mo (range: 3.6–12.2%).
Acceptability of supplements
There were no significant differences between groups regarding the mothers' responses to most questions about acceptability of the supplements (Table 6). Nearly all mothers liked giving the supplements to their children and believed that consumption of the supplements benefited their children's health; and 89–99% said that they would be willing to pay US$0.36 for a week's supply. The percentage of mothers who admitted giving the supplement alone (without mixing it with food, water, or juice) or in small doses several times in the day some of the time was significantly higher in the NB group (15% and 16%, respectively) than in the other 2 groups (3–4% and 3–10%, respectively). However, a significantly lower percentage of mothers in the NB group (16%) said that they sometimes mixed the supplement with foods other than fermented cereal porridge, in contrast with 48% in the SP and 36% in the NT group. More of the mothers in the NB group were willing to buy the supplement at each of the suggested prices (US$0.05/d or US$0.08/d) than were mothers in the other 2 groups. The mean amount that mothers in the NB group were willing to spend for a week's dose (US$0.74/wk) was significantly higher than the amount cited by mothers in the SP (US$0.56/wk) or NT (US$0.53/wk) groups.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONSUBJECTS AND METHODSRESULTSDISCUSSIONREFERENCES |
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The risk of anemia or iron deficiency at 12 mo was significantly lower in all 3 intervention groups than in the NI control group: 32% of the NI infants were anemic and 28% had iron deficiency anemia at 12 mo, whereas these rates were 15% and 9%, respectively, in the intervention groups. As was reported by others (7, 26), some anemia still remained in the intervention groups, even among the NT and NB children, who received a full complement of micronutrients. Although malaria could play a role (27), only 6.8% of the 44 intervention children with anemia at 12 mo were smear-positive for malaria, and we found no significant difference (t test; data not shown) in hemoglobin concentration between children with and without malaria in the 3 intervention groups. Other possible reasons could be infections and/or other factors such as sickle cell disease (28).
None of the 3 supplements had a significant effect on plasma zinc concentrations in the subsample of infants for whom this was assessed. This is not entirely surprising because, in our previous study in Ghana, a cereal-legume blend fortified with micronutrients (including zinc and iron) had no effect on plasma zinc after 6 mo of supplementation, compared with products without added micronutrients (2), and in South Africa, the addition of a Foodlet (compared with placebo) to complementary foods also did not affect plasma zinc (8). Possible reasons for this lack of response include 1) zinc absorption from these supplements, when added to maize-based complementary foods, may have been low, or 2) absorbed zinc may have been preferentially taken up by nonplasma pools.
Our results regarding the efficacy of these supplements for preventing anemia and iron deficiency are consistent with those of other studies of multiple micronutrient supplementation. Multiple micronutrient supplementation increased hemoglobin and iron status of Vietnamese infants (29) and 1–3-y-old Indian children (30). In Cambodia, SP with the same nutrient composition and concentration as those used in this study were effective in the treatment and prevention of anemia and for maintaining plasma ferritin concentrations, when added to complementary foods for 12 mo, between 6 and 18 mo of age (7). In a 4-nation study (31), the multiple micronutrient Foodlet, which had a composition comparable with the NT, had significant positive effects on hemoglobin and iron status in cohorts of Indonesian (32), Peruvian (26), South African (8), and Vietnamese (33) infants. Lopriore et al (34) showed that a highly nutrient-dense fat-based spread fortified with vitamins and minerals produced an 2-fold increase in hemoglobin concentration compared with a control group, although the children in that study were older. A smaller study in Malawi, in which a fat-based spread was provided to undernourished 6–17-mo-old-infants, also showed a significant effect on hemoglobin concentration (9).
The results of the exit interviews indicate that all 3 supplements were well accepted. No significant side effects were reported, because nearly all mothers reported no major problems feeding their children with the supplements. The fact that mothers were willing to pay relatively more for the NB suggests that mothers valued that supplement more than the other 2, possibly because it was packaged in a large (200 g), attractive sachet and was perceived as a food rather than as a powder or pill. In this study, each mother had experience with only 1 of the 3 supplements; therefore, it is not clear what their responses would have been if they had the option to decide which of the 3 they preferred most. However, our findings suggest that NB may receive high acceptance if the supplements were sold at an affordable price to mothers in a programmatic situation. The estimated cost of the dose of NB used in this study (20 g/d) is US$0.06–0.07/d, which is more than the estimated cost of powders or crushable tablets (US$0.02–0.03/d) but less than the mean amount that mothers in the NB group said that they would be willing to pay (US$0.10/d). We were not surprised that higher percentages of mothers in the NB group than in the other 2 groups said they sometimes gave the supplement alone or in small doses several times per day, given that the NB was perceived as a food, and the daily dose of 20 g was larger than the dose of the other 2 supplements. Given the growing concern about possible negative effects of iron-containing supplements (35, 36), administering the supplements in small doses throughout the day might be safer than giving them in a single meal. Mixing the supplements with foods other than cereal porridge some of the time allowed the mothers greater flexibility in their use.
The study had a few limitations. Although the NT and NB supplements were generally similar in the form and concentration of the nutrients that were common to both, we could not achieve the same composition with the SP because of logistical issues associated with their manufacture at the time of the study. Thus, whereas the NT and NB supplements contained 9 mg Fe as ferrous sulfate, the SP supplement contained 12.5 mg Fe as ferrous fumarate. However, iron absorption from ferrous fumarate is known to be significantly lower than that from ferrous sulfate (37); therefore, it is possible that SP did not provide any more absorbed iron to the infants than did NT and NB. A second limitation of this study was that it was not feasible to mask the mothers to the micronutrient supplements because of the different inherent characteristics of the products. However, the phlebotomist who measured hemoglobin concentrations and the technicians who performed the ferritin and TfR analyses were masked to group assignment. The same fieldworker who visited the mother during the intervention period also conducted the exit interview on acceptability, and it is possible that this could have influenced the mother's responses to the questions. To minimize this effect, we encouraged all mothers to give their frank opinions of the supplements. Another limitation of our design is that the home visits throughout the study period for the 3 supplement groups (but not the NI control group) may have influenced the amount of attention given to the children and, thus, the children's health status, even if no supplements had been provided (the Hawthorne effect). However, this does not affect the comparisons made across the 3 supplement groups. Strengths of the study were the low dropout rate (4.8%) and the lack of any significant difference in baseline characteristics between the dropouts and the participants. This suggests that the results are generalizable to the study population.
We conclude that all 3 micronutrient supplements were well accepted and had similar effects on iron status. Other results (10) also show that all 3 supplements significantly increased the odds of walking independently at 12 mo and that the NB supplement improved weight and length gain. Our study provides further evidence that home fortification of complementary foods with multiple micronutrient supplements is an effective option for reducing the prevalence of iron deficiency and anemia in children living in settings where iron-rich complementary foods are not available.
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ACKNOWLEDGMENTS |
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The authors' responsibilities were as follows—All authors were involved in study design. SA-A and KGD: participated in the implementation of the study, analysis and interpretation of the data, and the writing of the manuscript; AL and KHB: involved in the implementation of the study, interpretation of the data, and editing of the manuscript; and AB: assisted with the interpretation of the data. AB is currently a staff member of the World Health Organization and alone is responsible for the views expressed in this publication, which do not necessarily represent the decisions or stated policy of the World Health Organization. SZ owns the IP rights to SP. The HJ Heinz Company supports the technical development of SP on a cost-recovery basis. Any profit from royalty fees on the technology transfer of SP is currently being donated to the Hospital for Sick Children Foundation. Until December 2003, AB was a paid consultant of Nutriset, the company that manufactured the NB product. None of the other authors had any potential conflict of interest.
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This article has been cited by other articles:
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  L. M. Neufeld Ready-to-Use Therapeutic Food for the Prevention of Wasting in Children JAMA, January 21, 2009; 301(3): 327 - 328. [Full Text] [PDF]
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 J. C Phuka, K. Maleta, C. Thakwalakwa, Y. B. Cheung, A. Briend, M. J Manary, and P. Ashorn Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour Am. J. Clinical Nutrition, January 1, 2009; 89(1): 382 - 390. [Abstract] [Full Text] [PDF]
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 C. K. Lutter Iron Deficiency in Young Children in Low-Income Countries and New Approaches for Its Prevention J. Nutr., December 1, 2008; 138(12): 2523 - 2528. [Abstract] [Full Text] [PDF]
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R. J. Stoltzfus Research Needed to Strengthen Science and Programs for the Control of Iron Deficiency and Its Consequences in Young Children J. Nutr., December 1, 2008; 138(12): 2542 - 2546. [Abstract] [Full Text] [PDF]
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