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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Institut de Recherche en Sciences de la Sante, Burkina Faso

  collaborator OTHER_GOV

• AfricSanté, Burkina Faso

  collaborator UNKNOWN

• International Food Policy Research Institute

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University Ghent

  lead OTHER

Principal Investigators

• Patrick Kolsteren, Prof. dr. · University Ghent

• Carl Lachat, Prof. dr. · University Ghent

• Katrien W Vanslambrouck, MD · University Ghent

• Brenda PH de Kok, MSc. · University Ghent

• Lieven F Huybregts, PhD · IFPRI

• Laeticia Celine Toe, MD MSc. · IRSS

• Sheila Isanaka, Asst. Prof. · Harvard School of Public Health (HSPH)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

15 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-30

Primary Completion

2022-03-15

Completion

2022-03-15

Countries

• Burkina Faso

Study Locations