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Completed

NCT Number: NCT03533712

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

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.

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Key information

Conditions

Small for Gestational Age at Delivery Female Urogenital Diseases and Pregnancy Complications Infant Malnutrition Infant Nutrition Disorders Low Birth Weight Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Urogenital Diseases

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Houndé district

Houndé, Tuy, Burkina Faso

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fortified balanced energy-protein (BEP) supplement

Dietary 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

Dietary Supplement

Routine iron and folic acid supplementation.

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. Birth weight

    Time frame: within 72h after birth

  2. Birth length

    Time frame: within 72h after birth

  3. Chest circumference

    Time frame: within 72h after birth

  4. Head circumference

    Time frame: within 72h after birth

  5. Mid-upper arm circumference

    Time frame: within 72h after birth

  6. Gestational age

    Time frame: at delivery

  7. Preterm birth

    Time frame: at delivery

    Incidence of preterm birth at <37 weeks of gestation

  8. Large-for-gestational age

    Time frame: within 72h after birth

    Defined as a birth weight ≥90th centile intergrowth 21st reference

  9. Ponderal or Rohrer's index'

    Time frame: within 72 hours after birth

    Defined as birth weight/birth length3

  10. Fetal loss

    Time frame: during pregnancy

    Fetal death at <24 completed weeks of gestational age

  11. Stillbirths

    Time frame: during pregnancy

    Fetal death at ≥ 24 weeks gestational age

  12. 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

  13. 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

  14. 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

  15. 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 .

  16. 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.

  17. Maternal anemia

    Time frame: at the third antenatal consultation

    Hemoglobin concentration <11g/dL

  18. Weight-for-Age Z-score

    Time frame: at 6 months of age

    WAZ, calculated using the WHO growth reference

  19. Weight-for-Length Z-score

    Time frame: at 6 months of age

    WLZ, calculated using the WHO growth reference

  20. Stunting

    Time frame: at 6 months of age

    Length-for-Age Z-score (LAZ) <-2, calculated using the WHO growth reference

  21. Wasting

    Time frame: at 6 months of age

    Weight-for-Length Z-score (WLZ) <-2, calculated using the WHO growth reference

  22. Underweight

    Time frame: at 6 months of age

    Weight-for-Age Z-score (WAZ) <-2, calculated using the WHO growth reference

  23. Incidence of child wasting

    Time frame: over first 6 months of life

  24. Child weight gain

    Time frame: over first 6 months of life

    Monthly change in child weight

  25. Monthly change in LAZ

    Time frame: over first 6 months of life

  26. Monthly change in WHZ

    Time frame: over first 6 months of life

  27. Monthly change in WAZ

    Time frame: over first 6 months of life

  28. Monthly change in head circumference

    Time frame: over first 6 months of life

  29. Exclusive breastfeeding

    Time frame: during the first 6 months of life

    Duration of exclusive breastfeeding

  30. Child mortality

    Time frame: between birth and 6 months of age

  31. Child morbidity symptoms

    Time frame: over first 6 months of life

    Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose

  32. Child anemia

    Time frame: at 6 months of age

    Hemoglobin concentration <11g/dL

  33. Hemoglobin concentration

    Time frame: at 6 months of age

  34. Infant body composition

    Time frame: first 3 months of life

    Sub-sample

  35. Maternal body composition

    Time frame: first 3 months after delivery

    Sub-sample

  36. Breast milk composition

    Time frame: between 1-2 and 3-4 months

    Sub-sample

  37. 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • AfricSanté, Burkina Faso
  • Bill and Melinda Gates Foundation
  • Harvard School of Public Health (HSPH)
  • Institut de Recherche en Sciences de la Sante, Burkina Faso
  • International Food Policy Research Institute
  • University of California, Davis

Registry information

Acronym: MISAME-3

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 23, 2018
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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