Reproductive Health Working Group > PROMISE

PRegnancy Outcome and MIcronutrient Supplementation in Ethiopia (PROMISE). The effect of perinatal micronutrient supplementation: A randomised study.

Project period: 2008-2011

Project team:

• Professor Henrik Friis, Dept Human Nutrition, KU-LIFE, Denmark
• Assistant Professor Tsinuel Girma, Dept of Paediatrics, Jimma University, Ethiopia

Partner institutions: Jimma University, Ethiopia

Project Description:

Background: Pregnant women are considered at increased risk of micronutrient deficiencies because nutritional needs are increased during pregnancy. UNICEF ten years ago suggested changing the recommendations for prenatal micronutrient supplementation from the existing iron and folic acid supplement to multi-micronutrients. However, results from trials testing the suggested supplement containing 1 DRI (daily recommended intake) are disappointing with relatively small effects on BW which was apparently not accompanied by a reduction in neonatal mortality as expected. The main outcome in most studies was birth weight which may be too rough to predict survival. Body composition is most likely a better predictor of survival than is body weight. Further, few studies have obtained promising results of micronutrient supplementation in high doses, particularly vitamins B, C and E (BCE). In the PROMISE study we will assess the effect of perinatal supplementation with BCE in addition to other essential micronutrients.

Aim: To evaluate the effect of high dose perinatal multi-micronutrient supplementation on birth weight and body composition. Further, the effects on infant morbidity and mortality, motor milestones, and prevalence of maternal anaemia will be assessed. Analyses will be stratified by HIV status.

Methodology: The study is a randomised, controlled trial in which two different high dose micronutrient supplements are compared with the standard of care in antenatal supplementation (iron and folic acid). A total of 8000 pregnant women are given a daily supplement of A) 2 DRI of 15 micronutrients including iron and folic acid, B) the same as A, but with higher doses of BCE from first antenatal contact until three months after delivery, or C) iron and folic acid until delivery followed by placebo until three months after delivery. Birth anthropometry will be measured using standard methods and body composition of newborns will be measured using air displacement plethysmography (Peapod). Infants and mothers will be followed closely during the first year of life during which growth, change in body composition, hospitalisations and mortality will be assessed.

Scope of study: This study will provide knowledge to support the decision whether public multi-micronutrient supplementation should be part of the international recommendations for antenatal care.

Project budget: Total 12.7 mio DKK (Danida, FØSU, Novo, Forskningsrådet for Sundhed og Sygdom).