Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
NCT ID: NCT03533712
Last Updated: 2022-03-22
Study Results
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Basic Information
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COMPLETED
PHASE4
1788 participants
INTERVENTIONAL
2019-10-30
2022-03-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Fortified BEP supplement
Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid 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.
Fe and folic acid
Dietary Supplement: Fe and folic acid supplement.
Fe and folic acid supplement
Routine iron and folic acid supplementation.
Interventions
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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.
Fe and folic acid supplement
Routine iron and folic acid supplementation.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
15 Years
40 Years
FEMALE
Yes
Sponsors
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Harvard School of Public Health (HSPH)
OTHER
Institut de Recherche en Sciences de la Sante, Burkina Faso
OTHER_GOV
AfricSanté, Burkina Faso
UNKNOWN
International Food Policy Research Institute
OTHER
University of California, Davis
OTHER
Bill and Melinda Gates Foundation
OTHER
University Ghent
OTHER
Responsible Party
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VakgroepLevensmiddelentechnologieVoedselveiligheidGezondheid
Prof. dr. Patrick Kolsteren
Principal Investigators
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Patrick Kolsteren, Prof. dr.
Role: STUDY_CHAIR
University Ghent
Carl Lachat, Prof. dr.
Role: STUDY_DIRECTOR
University Ghent
Katrien W Vanslambrouck, MD
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Brenda PH de Kok, MSc.
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Lieven F Huybregts, PhD
Role: PRINCIPAL_INVESTIGATOR
IFPRI
Laeticia Celine Toe, MD MSc.
Role: PRINCIPAL_INVESTIGATOR
IRSS
Sheila Isanaka, Asst. Prof.
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Locations
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Houndé district
Houndé, Tuy, Burkina Faso
Countries
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References
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Argaw A, Toe LC, Hanley-Cook G, Dailey-Chwalibog T, de Kok B, Ouedraogo L, Compaore A, Ouedraogo M, Sawadogo A, Ganaba R, Vanslambrouck K, Kolsteren P, Lachat C, Huybregts L. Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso. PLoS Med. 2023 Jul 24;20(7):e1004242. doi: 10.1371/journal.pmed.1004242. eCollection 2023 Jul.
Argaw A, de Kok B, Toe LC, Hanley-Cook G, Dailey-Chwalibog T, Ouedraogo M, Compaore A, Vanslambrouck K, Ganaba R, Kolsteren P, Lachat C, Huybregts L. Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 x 2 factorial individually randomized controlled trial. PLoS Med. 2023 Feb 6;20(2):e1004186. doi: 10.1371/journal.pmed.1004186. eCollection 2023 Feb.
Hanley-Cook G, Toe LC, Tesfamariam K, de Kok B, Argaw A, Compaore A, Ouedraogo M, Dailey-Chwalibog T, Kolsteren P, Lachat C, Huybregts L. Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso. J Nutr. 2022 Oct 6;152(10):2277-2286. doi: 10.1093/jn/nxac171.
de Kok B, Toe LC, Hanley-Cook G, Argaw A, Ouedraogo M, Compaore A, Vanslambrouck K, Dailey-Chwalibog T, Ganaba R, Kolsteren P, Huybregts L, Lachat C. Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial. PLoS Med. 2022 May 13;19(5):e1004002. doi: 10.1371/journal.pmed.1004002. eCollection 2022 May.
Hanley-Cook GT, Argaw A, de Kok B, Toe LC, Dailey-Chwalibog T, Ouedraogo M, Kolsteren P, Huybregts L, Lachat C. Seasonality and Day-to-Day Variability of Dietary Diversity: Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso. J Nutr. 2022 Sep 6;152(9):2145-2154. doi: 10.1093/jn/nxac104.
de Kok B, Argaw A, Hanley-Cook G, Toe LC, Ouedraogo M, Dailey-Chwalibog T, Diop L, Becquey E, Kolsteren P, Lachat C, Huybregts L. Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso. J Nutr. 2021 Dec 3;151(12):3831-3840. doi: 10.1093/jn/nxab289.
Vanslambrouck K, de Kok B, Toe LC, De Cock N, Ouedraogo M, Dailey-Chwalibog T, Hanley-Cook G, Ganaba R, Lachat C, Huybregts L, Kolsteren P. Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 24;11(3):e038393. doi: 10.1136/bmjopen-2020-038393.
Other Identifiers
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OPP1175213
Identifier Type: -
Identifier Source: org_study_id
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