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Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso. (MISAME-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03533712
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : March 22, 2022
Sponsor:
Collaborators:
Harvard School of Public Health (HSPH)
Institut de Recherche en Sciences de la Sante, Burkina Faso
AfricSanté, Burkina Faso
International Food Policy Research Institute
University of California, Davis
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
VakgroepLevensmiddelentechnologieVoedselveiligheidGezondheid, University Ghent

Study Description
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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.


Condition or disease Intervention/treatment Phase
Small for Gestational Age at Delivery Low Birth Weight Prematurity Infant Malnutrition Dietary Supplement: Fortified balanced energy-protein (BEP) supplement Dietary Supplement: Fe and folic acid supplement Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1788 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
Actual Study Start Date : October 30, 2019
Actual Primary Completion Date : March 15, 2022
Actual Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fortified BEP supplement
Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement.
 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.
Active Comparator: Fe and folic acid
Dietary Supplement: Fe and folic acid supplement.
 Dietary Supplement: Fe and folic acid supplement
Routine iron and folic acid supplementation.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533712


Locations
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Burkina Faso
Houndé district
Houndé, Tuy, Burkina Faso
Sponsors and Collaborators
University Ghent
Harvard School of Public Health (HSPH)
Institut de Recherche en Sciences de la Sante, Burkina Faso
AfricSanté, Burkina Faso
International Food Policy Research Institute
University of California, Davis
Bill and Melinda Gates Foundation
Investigators
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Study Chair: Patrick Kolsteren, Prof. dr. University Ghent
Study Director: Carl Lachat, Prof. dr. University Ghent
Principal Investigator: 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)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VakgroepLevensmiddelentechnologieVoedselveiligheidGezondheid, Prof. dr. Patrick Kolsteren, University Ghent
ClinicalTrials.gov Identifier: NCT03533712    
Other Study ID Numbers: OPP1175213
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share study data with a similar study ongoing in Nepal.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Infant Nutrition Disorders
Birth Weight
Nutrition Disorders
Body Weight
Folic Acid
 Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs