Clinical trial NCT03533712: Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
Official title: Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Small for Gestational Age at Delivery
Low Birth Weight
Prematurity
Infant Malnutrition
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: AfricSanté, Burkina Faso
name: International Food Policy Research Institute
name: University of California, Davis
name: Bill and Melinda Gates Foundation
First posted: 2018-05-23
Enrollment: 1788
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Small-for-Gestational-age (SGA)
timeFrame: within 72h after birth
measure: Length-for-age Z-scores (LAZ)
timeFrame: at 6 months (and 12 months on a subsample)
Secondary outcomes:
measure: Birth weight
timeFrame: within 72h after birth
measure: Birth length
timeFrame: within 72h after birth
measure: Chest circumference
timeFrame: within 72h after birth
measure: Head circumference
timeFrame: within 72h after birth
measure: Mid-upper arm circumference
timeFrame: within 72h after birth
measure: Gestational age
timeFrame: at delivery
measure: Preterm birth
timeFrame: at delivery
measure: Large-for-gestational age
timeFrame: within 72h after birth
measure: Ponderal or Rohrer's index'
timeFrame: within 72 hours after birth
measure: Fetal loss
timeFrame: during pregnancy
measure: Stillbirths
timeFrame: during pregnancy
measure: Neonatal mortality
timeFrame: between birth and ≤ 28 days of life
measure: Prenatal weight gain
timeFrame: between study inclusion until just before delivery
measure: Gestational weight change
timeFrame: between study inclusion until 1 month after delivery
measure: Probable and possible maternal postnatal depression
timeFrame: (1) at 2 months of child age; (2) at 6 months of child age
measure: Women's minimum and mean dietary diversity score
timeFrame: from study inclusion until delivery
measure: Maternal anemia
timeFrame: at the third antenatal consultation
measure: Weight-for-Age Z-score
timeFrame: at 6 months of age
measure: Weight-for-Length Z-score
timeFrame: at 6 months of age
measure: Stunting
timeFrame: at 6 months of age
measure: Wasting
timeFrame: at 6 months of age
measure: Underweight
timeFrame: at 6 months of age
measure: Incidence of child wasting
timeFrame: over first 6 months of life
measure: Child weight gain
timeFrame: over first 6 months of life
measure: Monthly change in LAZ
timeFrame: over first 6 months of life
measure: Monthly change in WHZ
timeFrame: over first 6 months of life
measure: Monthly change in WAZ
timeFrame: over first 6 months of life
measure: Monthly change in head circumference
timeFrame: over first 6 months of life
measure: Exclusive breastfeeding
timeFrame: during the first 6 months of life
measure: Child mortality
timeFrame: between birth and 6 months of age
measure: Child morbidity symptoms
timeFrame: over first 6 months of life
measure: Child anemia
timeFrame: at 6 months of age
measure: Hemoglobin concentration
timeFrame: at 6 months of age
measure: Infant body composition
timeFrame: first 3 months of life
measure: Maternal body composition
timeFrame: first 3 months after delivery
measure: Breast milk composition
timeFrame: between 1-2 and 3-4 months
measure: Relative average telomere length
timeFrame: At birth
Other outcomes:
Locations:
city: Houndé
country: Burkina Faso
facility: Houndé district
state: Tuy
Study officials:
affiliation: University Ghent
name: Patrick Kolsteren, Prof. dr.
role: STUDY_CHAIR
affiliation: University Ghent
name: Carl Lachat, Prof. dr.
role: STUDY_DIRECTOR
affiliation: University Ghent
name: Katrien W Vanslambrouck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Brenda PH de Kok, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: IFPRI
name: Lieven F Huybregts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRSS
name: Laeticia Celine Toe, MD MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Sheila Isanaka, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.