Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso. (MISAME-3)
- Patrick Kolsteren
Study PeriodNovember 2019 - November 2022
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.
- Experimental: Fortified BEP supplement Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement.
- Active Comparator: Fe and folic acid Dietary Supplement: Routine iron and folic acid supplementation.
- Small-for-Gestational-age (SGA) [ Time Frame: within 72h after birth ] Incidence of Small-for-Gestational-age (SGA) defined as <10th centile of birthweight for gestational age standard, InterGrowth 21st reference.
- Length-for-age Z-scores (LAZ) [ Time Frame: at 6 months (and 12 months on a subsample) ] Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.
- Standard Fortified Food Blends
Which food products do recipients enjoy eating and have the fewest side effects?
Which ingredients offer the best prevention or treatment for undernutrition?
How well do different food compositions and interventions prevent or treat undernutrition, when implemented in a completely controlled environment?
How are supplementary foods dispersed and shared within a household or community? How does their actual use differ from intended use?