Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso. (MISAME-3)

Primary Investigator

  • Patrick Kolsteren

Study Period

November 2019 - November 2022

Study 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.

 

Study Arms

  • 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.

Primary Outcomes

  • 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.

Study Intervention

  • Standard Fortified Food Blends

Research Gaps

  • Acceptability

    Which food products do recipients enjoy eating and have the fewest side effects?

  • Composition

    Which ingredients offer the best prevention or treatment for undernutrition?

  • Efficacy

    How well do different food compositions and interventions prevent or treat undernutrition, when implemented in a completely controlled environment?

  • Use

    How are supplementary foods dispersed and shared within a household or community? How does their actual use differ from intended use?

Study Population

1776