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American Journal of Clinical Nutrition, Vol. 88, No. 5, 1330-1340, November 2008
© 2008 American Society for Nutrition


ORIGINAL RESEARCH COMMUNICATION

Effects of maternal multiple micronutrient supplementation on fetal growth: a double-blind randomized controlled trial in rural Burkina Faso1,2,3

Dominique Roberfroid1, Lieven Huybregts1, Hermann Lanou1, Marie-Claire Henry1, Nicolas Meda1, Joris Menten1, Patrick Kolsteren1 for the MISAME Study Group1

1 From the Child Health and Nutrition Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium (DR, JM, and PK); the Center Muraz, Ministry of Health, Bobo-Dioulasso, Burkina Faso (HL, M-CH, and NM); and the Department of Food Safety and Food Quality, Ghent University, Belgium (LH)

Background: Intrauterine growth retardation is a major predictor of child health in developing countries.

Objective: We tested whether providing pregnant women with the UNICEF/WHO/UNU international multiple micronutrient preparation (UNIMMAP), rather than iron and folic acid alone, improved fetal growth and its correlates.

Design: An intention-to-treat, double-blind, randomized controlled trial including 1426 pregnancies was carried out in rural Burkina Faso. Tablet intake was directly observed.

Results: Pregnancy outcome was known in 96.3% of the participants. After adjustment for gestational age at delivery, both birth weight (52 g; 95% CI: 4, 100; P = 0.035) and birth length (3.6 mm; 95% CI: 0.8, 6.3; P = 0.012) were significantly higher in the UNIMMAP group. UNIMMAP had a differential effect by percentiles of birth weight and length distributions: the risk of large-for-gestational-age infants was higher in the UNIMMAP group (OR: 1.58; 95% CI: 1.04, 2.38; P = 0.03), although the risk of low birth weight remained unchanged. The effect of UNIMMAP on birth size was modified by maternal body mass index at enrollment and could be more important in multiparous women and women taking sulfadoxine-pyrimethamine. Unexpectedly, the risk of perinatal death was marginally significantly increased in the UNIMMAP group (OR: 1.78; 95% CI: 0.95, 3.32; P = 0.07), and this seemed to affect mainly primiparous women (OR: 3.44; 95% CI: 1.1, 10.7; P for interaction = 0.11).

Conclusions: Maternal UNIMMAP modestly but significantly increased fetal growth. The resulting benefit on infant growth and survival needs to be assessed. The possible lack of benefit and potential harm in primiparous women should be further investigated. This trial was registered at clinicaltrials.gov as NCT00642408.







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