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ORIGINAL RESEARCH COMMUNICATION |
1 From the Department of Food Safety and Food Quality, Ghent University, Ghent, Belgium (LH, HL, JVC, and PK); the Child Health and Nutrition Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium (DR, JM, and PK); the Centre Muraz, Ministry of Health, Bobo-Dioulasso, Burkina Faso (NM); and IRSS, Ouagadougou, Burkina Faso (HL).
2 None of the sponsors had any role in the study design, data collection, data analysis, or writing of the report.
3 Supported by Flemish University Council, Nutrition Third World, and the Belgian Ministry of Development. The multiple micronutrient premix was donated by Nutriset, France.
4 Address correspondence to P Kolsteren, Child Health and Nutrition Unit, Department of Public Health, Institute of Tropical Medicine, 155, Nationalestraat, 2000 Antwerp, Belgium. E-mail: pkolsteren{at}itg.be.
for the MISAME Study Group
Background: Prenatal multiple micronutrient (MMN) or balanced energy and protein supplementation has a limited effect on birth size of the offspring.
Objective: The objective was to determine whether a prenatal MMN-fortified food supplement (FFS) improves anthropometric measures at birth compared with supplementation with an MMN pill alone.
Design: We conducted a nonblinded, individually randomized controlled trial in 1296 pregnant women in 2 villages in rural Burkina Faso. Supplements were provided on a daily basis, and compliance was closely verified by using a community-based network of home visitors.
Results: Anthropometric measures at birth were available for analysis for 87% of the 1175 live singleton deliveries enrolled. After adjustment for gestational age at birth, the FFS group had a significantly higher birth length (+4.6 mm; P = 0.001). FFS supplementation resulted in a modestly higher birth weight (+31 g; P = 0.197). Subgroup analyses showed clinically important treatment effects on birth length (+12.0 mm; P = 0.005) and on birth weight (+111 g; P = 0.133) for underweight [body mass index (in kg/m2) <18.5] pregnant women. Women with early pregnancy anemia who received FFS gave birth to longer newborns (+7.3 mm; P = 0.002) than did those who received MMN supplementation.
Conclusions: The provision of FFS to pregnant women resulted in higher birth length than did MMN supplementation. For women with a suboptimal prepregnancy nutritional status, MMN supplementation should be complemented with a balanced energy and protein supplement to produce a clinical effect on birth size. The trial was registered at clinicaltrials.gov as NCT00909974.