NCT03533712

Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,788 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: Female
• Age: 15 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Small for Gestational Age at Delivery
• Low Birth Weight
• Prematurity
• Infant Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fortified balanced energy-protein (BEP) supplement	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.
DIETARY_SUPPLEMENT	Fe and folic acid supplement	Routine iron and folic acid supplementation.

Timeline

• Start date: 2019-10-30
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2018-05-23
• Last updated: 2022-03-22

Locations

1 site across 1 country: Burkina Faso