Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
Condition: Small for Gestational Age at Delivery; Low Birth Weight; Prematurity; Infant Malnutrition
MeSH terms: Malnutrition; Infant Nutrition Disorders; Birth Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished
      populations should receive fortified balanced energy-protein (BEP) supplements to reduce the
      risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and
      delivery channels must be determined for different contexts.

      The present proposal therefore will 1) perform a formative study to identify the most
      suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina
      Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal
      and infant growth (phase 2). The nutritional composition of the BEP supplement was
      established during an expert convening at the BMGF in September 2016. Private sector partners
      will prepare the supplements in the selected forms with the recommended nutrient composition.
    

Detailed description: 
      Pregnancy remains a challenging period in the life of many women in low- and middle-income
      countries. Maternal mortality remains high and many newborns suffer from premature delivery
      and /or gestational growth retardation both in length and in weight accumulation.

      The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished
      populations should receive fortified balanced energy-protein (BEP) supplements to reduce the
      risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and
      delivery channels must be determined for different contexts.

      The purpose of this study is to assess the efficacy of a fortified BEP supplement for
      pregnant and lactating women to improve birth weight, fetal and infant growth.

      This research includes 2 phases:

        -  Phase 1 - part 1: Formative research to identify preferred product types of a fortified
           BEP supplement;

        -  Phase 1 - part 2: Formative research with a 10-week home-feeding trial to determine the
           acceptability of a fortified BEP supplement for longer-term consumption.

        -  Phase 2: A community-based, individually randomized efficacy trial of the fortified BEP
           food supplement including 1,776 pregnant and lactating women aimed at testing 2
           hypothesis: supplementing pregnant and lactating women with a fortified BEP supplement
           will improve fetal growth; improving fetal growth will have a positive effect on health
           and growth during infancy.
    

Intervention name(s): Fortified balanced energy-protein (BEP) supplement; Fe and folic acid supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The product contains the following target nutrients:
Total energy: 250-500 kcal per daily serving
Fat content: 10-60% of energy intake
Protein content: 16 g (range 14-18 g) with a Digestible Indispensable Amino Acid Score (DIAAS) of ≥ 0.9
Carbohydrate (CHO) Content: no specific recommendations, relative to fat and protein content.
Trans Fats: <1% energy intake Micronutrients include the following: A, D, E, K, B1 (thiamin), B2 (riboflavin), B3 (niacin), B6 (pyridoxine), B9 (folate), B12 and C; minerals: iron, zinc, iodine, calcium, phosphorous, copper, and selenium.
The final composition of macro en micronutrients will be available after the acceptability testing (phase 1) and will be determined by 1) the product type and 2) the preferred taste.; Routine iron and folic acid supplementation.
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The intervention study is a randomized controlled 2x2 factorial efficacy trial. At study inclusion, eligible pregnant women will be randomly assigned to the prenatal intervention or control group, and randomly assigned to a postnatal intervention or control group. The intervention group will receive daily a fortified BEP supplement to be consumed under supervision for the duration of pregnancy/lactation. Both control and intervention group will receive the standard iron and folic acid tablet through the regular ante natal care program.
Masking: None (Open Label)
Primary purpose: Prevention