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

University Ghent

Status and phase: Completed; Phase 4

Conditions: Infant Malnutrition; Prematurity; Small for Gestational Age at Delivery; Low Birth Weight

Treatments: Dietary Supplement: Fe and folic acid supplement; Dietary Supplement: Fortified balanced energy-protein (BEP) supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03533712

OPP1175213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,788 patients

Sex: Female

Ages: 15 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,788 participants in 2 patient groups

Fortified BEP supplement

Experimental group

Description:

Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement.

Treatment:

Dietary Supplement: Fortified balanced energy-protein (BEP) supplement

Fe and folic acid

Active Comparator group

Description:

Dietary Supplement: Fe and folic acid supplement.

Treatment:

Dietary Supplement: Fe and folic acid supplement