Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Infant Malnutrition
- Low Birth Weight
- Prematurity
- Small for Gestational Age at Delivery
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention 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
Participation Requirements
- Age
- Between 15 years and 40 years
- Gender
- Only males
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 guideli...
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.
Tracking Information
- NCT #
- NCT03533712
- Collaborators
- Harvard School of Public Health
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- AfricSanté, Burkina Faso
- International Food Policy Research Institute
- University of California, Davis
- Bill and Melinda Gates Foundation
- Investigators
- Study Chair: Patrick Kolsteren, Prof. dr. University Ghent Study Director: Carl Lachat, Prof. dr. University Ghent Principal Investigator: Katrien W Vanslambrouck, MD University Ghent Principal Investigator: Brenda PH de Kok, MSc. University Ghent Principal Investigator: Lieven F Huybregts, PhD IFPRI Principal Investigator: Laeticia Celine Toe, MD MSc. IRSS Principal Investigator: Sheila Isanaka, Asst. Prof. Harvard School of Public Health
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