CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,788 enrolled
Drug / intervention
Fortified balanced energy-protein (BEP) supplement +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03533712
NCT03533712Phase 4Completed
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Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

University Ghent·interventional·Posted May 23, 2018·Updated Mar 22, 2022

In Brief

A Phase 4 clinical trial evaluating Fortified balanced energy-protein (BEP) supplement and Fe and folic acid supplement for Small for Gestational Age at Delivery and 3 related conditions. Completed, enrolled 1,788 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall for Gestational Age at Delivery, Low Birth Weight, Prematurity, Infant Malnutrition
CountriesBurkina Faso
CollaboratorsHarvard School of Public Health (HSPH), 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

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 23, 2018
Enrollment StartOct 30, 2019
Primary CompletionMar 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.1 years ago

Interventions

Fortified balanced energy-protein (BEP) supplementdietary

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.

Fe and folic acid supplementdietary

Routine iron and folic acid supplementation.