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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 15, 2022

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.

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.

Arms, Groups and Cohorts

  • Experimental: Fortified BEP supplement
    • Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement.
  • Active Comparator: Fe and folic acid
    • Dietary Supplement: Fe and folic acid supplement.

Clinical Trial Outcome Measures

Primary Measures

  • Small-for-Gestational-age (SGA)
    • Time Frame: within 72h after birth
    • Incidence of Small-for-Gestational-age (SGA) defined as <10th centile of birthweight for gestational age standard, InterGrowth 21st reference.
  • Length-for-age Z-scores (LAZ)
    • Time Frame: at 6 months (and 12 months on a subsample)
    • Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.

Secondary Measures

  • Birth weight
    • Time Frame: within 72h after birth
  • Birth length
    • Time Frame: within 72h after birth
  • Chest circumference
    • Time Frame: within 72h after birth
  • Head circumference
    • Time Frame: within 72h after birth
  • Mid-upper arm circumference
    • Time Frame: within 72h after birth
  • Gestational age
    • Time Frame: at delivery
  • Preterm birth
    • Time Frame: at delivery
    • Incidence of preterm birth at <37 weeks of gestation
  • Large-for-gestational age
    • Time Frame: within 72h after birth
    • Defined as a birth weight ≥90th centile intergrowth 21st reference
  • Ponderal or Rohrer’s index’
    • Time Frame: within 72 hours after birth
    • Defined as birth weight/birth length3
  • Fetal loss
    • Time Frame: during pregnancy
    • Fetal death at <24 completed weeks of gestational age
  • Stillbirths
    • Time Frame: during pregnancy
    • Fetal death at ≥ 24 weeks gestational age
  • Neonatal mortality
    • Time Frame: between birth and ≤ 28 days of life
    • (1) Early neonatal mortality: deaths between birth and ≤ 7 days of life; (2) Neonatal mortality: deaths between birth and ≤28 days of life; (3) Late neonatal mortality deaths between >7 days and ≤28 days of life
  • Prenatal weight gain
    • Time Frame: between study inclusion until just before delivery
    • Weight change between study inclusion until just before delivery: total and trimester specific
  • Gestational weight change
    • Time Frame: between study inclusion until 1 month after delivery
    • Difference in maternal weight between maternal weight one month after delivery and maternal weight at study inclusion
  • Probable and possible maternal postnatal depression
    • Time Frame: (1) at 2 months of child age; (2) at 6 months of child age
    • Measured using the 10-item Edinburgh postnatal depression scale. Probable depression is defined as EPDS>12. Possible depression is defined as EPDS>9 .
  • Women’s minimum and mean dietary diversity score
    • Time Frame: from study inclusion until delivery
    • Measured biweekly using the 10 food group indicator as proposed by FAO. Minimum dietary diversity is defined as having consumed at least 5 food groups over the last 24 hours.
  • Maternal anemia
    • Time Frame: at the third antenatal consultation
    • Hemoglobin concentration <11g/dL
  • Weight-for-Age Z-score
    • Time Frame: at 6 months of age
    • WAZ, calculated using the WHO growth reference
  • Weight-for-Length Z-score
    • Time Frame: at 6 months of age
    • WLZ, calculated using the WHO growth reference
  • Stunting
    • Time Frame: at 6 months of age
    • Length-for-Age Z-score (LAZ) <-2, calculated using the WHO growth reference
  • Wasting
    • Time Frame: at 6 months of age
    • Weight-for-Length Z-score (WLZ) <-2, calculated using the WHO growth reference
  • Underweight
    • Time Frame: at 6 months of age
    • Weight-for-Age Z-score (WAZ) <-2, calculated using the WHO growth reference
  • Incidence of child wasting
    • Time Frame: over first 6 months of life
  • Child weight gain
    • Time Frame: over first 6 months of life
    • Monthly change in child weight
  • Monthly change in LAZ
    • Time Frame: over first 6 months of life
  • Monthly change in WHZ
    • Time Frame: over first 6 months of life
  • Monthly change in WAZ
    • Time Frame: over first 6 months of life
  • Monthly change in head circumference
    • Time Frame: over first 6 months of life
  • Exclusive breastfeeding
    • Time Frame: during the first 6 months of life
    • Duration of exclusive breastfeeding
  • Child mortality
    • Time Frame: between birth and 6 months of age
  • Child morbidity symptoms
    • Time Frame: over first 6 months of life
    • Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose
  • Child anemia
    • Time Frame: at 6 months of age
    • Hemoglobin concentration <11g/dL
  • Hemoglobin concentration
    • Time Frame: at 6 months of age
  • Infant body composition
    • Time Frame: first 3 months of life
    • Sub-sample
  • Maternal body composition
    • Time Frame: first 3 months after delivery
    • Sub-sample
  • Breast milk composition
    • Time Frame: between 1-2 and 3-4 months
    • Sub-sample
  • Relative average telomere length
    • Time Frame: At birth
    • The umbilical cord blood will be analyzed to verify telomere length using qPCR on a sub-sample. Telomere lengths will be expressed as the ratio of telomere copy number to single-copy gene number (T/S) relative to the mean T/S ratio of the entire sample.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Ghent
  • Collaborator
    • Harvard School of Public Health (HSPH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: VakgroepLevensmiddelentechnologieVoedselveiligheidGezondheid, Prof. dr. Patrick Kolsteren – University Ghent
  • Overall Official(s)
    • Patrick Kolsteren, Prof. dr., Study Chair, University Ghent
    • Carl Lachat, Prof. dr., Study Director, University Ghent
    • Katrien W Vanslambrouck, MD, Principal Investigator, University Ghent
    • Brenda PH de Kok, MSc., Principal Investigator, University Ghent
    • Lieven F Huybregts, PhD, Principal Investigator, IFPRI
    • Laeticia Celine Toe, MD MSc., Principal Investigator, IRSS
    • Sheila Isanaka, Asst. Prof., Principal Investigator, Harvard School of Public Health (HSPH)

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