Official Title
Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
Phase
Phase 4Lead Sponsor
Ghent UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Small for Gestational Age at Delivery Low Birth Weight Prematurity Infant MalnutritionIntervention/Treatment
Fe and folic acid supplement [iron (2857), folic acid (30563)] ...Study Participants
1788The 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.
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.
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: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement.
Dietary Supplement: Fe and folic acid supplement.
Inclusion Criteria: Participant age (15-40 years). Pregnant as determined by a pregnancy test and confirmed by ultrasound. Women who signed the informed consent form (in case of minors the parents or husband signs) Exclusion Criteria: Women planning to leave the area before delivery. Women who plan to deliver outside the area. Pregnancies with a gestational age > 20 weeks at study inclusion. Women with multi-fetal gestation (exclusion from analysis). Women who are allergic to peanuts.
