NCT03533712

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,788

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

April 23, 2018

Last Update Submit

March 21, 2022

Conditions

Small for Gestational Age at DeliveryLow Birth WeightPrematurityInfant Malnutrition

Outcome Measures

Primary Outcomes (2)

  • Small-for-Gestational-age (SGA)

    Incidence of Small-for-Gestational-age (SGA) defined as \<10th centile of birthweight for gestational age standard, InterGrowth 21st reference.

    within 72h after birth

  • Length-for-age Z-scores (LAZ)

    Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.

    at 6 months (and 12 months on a subsample)

Secondary Outcomes (37)

  • Birth weight

    within 72h after birth

  • Birth length

    within 72h after birth

  • Chest circumference

    within 72h after birth

  • Head circumference

    within 72h after birth

  • Mid-upper arm circumference

    within 72h after birth

  • +32 more secondary outcomes

Study Arms (2)

Fortified BEP supplement

EXPERIMENTAL

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

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

Fe and folic acid

ACTIVE COMPARATOR

Dietary Supplement: Fe and folic acid supplement.

Dietary Supplement: Fe and folic acid supplement

Interventions

Fortified balanced energy-protein (BEP) supplementDIETARY_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.

Fortified BEP supplement
Fe and folic acid supplementDIETARY_SUPPLEMENT

Routine iron and folic acid supplementation.

Fe and folic acid

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Women planning to leave the area before delivery.
  • Women who plan to deliver outside the area.
  • Women who are allergic to peanuts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houndé district

Houndé, Tuy, Burkina Faso

Location

Related Publications (7)

  • 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.

    PMID: 37486952DERIVED

  • 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.

    PMID: 36745684DERIVED

  • 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.

    PMID: 35906874DERIVED

  • 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.

    PMID: 35560315DERIVED

  • 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.

    PMID: 35524695DERIVED

  • 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.

    PMID: 34494113DERIVED

  • 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.

    PMID: 33762226DERIVED

MeSH Terms

Conditions

Premature BirthInfant Nutrition Disorders

Interventions

BEP protocol

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Patrick Kolsteren, Prof. dr.

    University Ghent

    STUDY CHAIR

  • Carl Lachat, Prof. dr.

    University Ghent

    STUDY DIRECTOR

  • 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 (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Patrick Kolsteren

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 23, 2018

Study Start

October 30, 2019

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Share study data with a similar study ongoing in Nepal.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BU(1)