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

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ClinicalTrials.gov Identifier: NCT03533712
Recruitment Status : Not yet recruiting
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
Harvard School of Public Health
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):
Department of Food Technology, Safety and Health, University Ghent

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) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 3). 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 3 phases:

  • Phase 1: Formative research to identify preferred product types of a fortified BEP supplement;
  • Phase 2: Formative research with an 8-week home-feeding trial to determine the acceptability of a fortified BEP supplement for longer-term consumption.
  • Phase 3: 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1776 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The intervention study will be an individually randomized efficacy trial. Pregnant women will be individually and randomly allocated to an intervention and a control group using a pre-defined randomization schedule. The intervention group will receive daily a fortified BEP supplement to be consumed under supervision for the duration of pregnancy. Both control and intervention group will receive the standard iron and folic acid tablet through the regular ante natal care program. After birth, mothers will be re-randomized individually to either a lactation supplement group or a control. The participants of the intervention and the control group will be assigned to intervention and control to have a balanced allocation.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome in Houndé District, Burkina Faso.
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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 + 2) 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.




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) ]
    Incidence of Length-for-age Z-scores (LAZ), WHO multi-country reference.


Secondary Outcome Measures :
  1. Birth length [ Time Frame: within 72h after birth ]
  2. Incidence of preterm birth [ Time Frame: at birth ]
    <37 weeks gestation

  3. Birth weight [ Time Frame: within 72h after birth ]
  4. Chest circumference [ Time Frame: within 72h after birth ]
  5. Head circumference [ Time Frame: within 72h after birth ]
  6. Weight-for-age Z-score [ Time Frame: at 6 months (and 12 months on a subsample) ]
  7. Weight-for-length Z-score [ Time Frame: at 6 months (and 12 months on a subsample) ]
  8. Infant body composition [ Time Frame: first 3 months of life ]
  9. Breast milk composition [ Time Frame: between 1-2 and 3-4 months ]
  10. Morbidity [ Time Frame: monthly, up to 6 months after delivery (and up to 9 or 12 months on a subsample) ]


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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Participant age (15-35 years).

Exclusion Criteria:

  • Women planning to leave the area before delivery.
  • Women who plan to deliver outside the area.
  • Women who have an illness that might have an influence on birth outcome.

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


Contacts
Contact: Patrick W Kolsteren, Prof. dr. +3292649377 Patrick.Kolsteren@Ugent.be
Contact: Carl Lachat, Prof. dr. +3292649377 Carl.Lachat@Ugent.be

Locations
Burkina Faso
Houndé district Not yet recruiting
Houndé, Tuy, Burkina Faso
Contact: Laeticia Celine Toe, MD       cellaety@yahoo.fr   
Sponsors and Collaborators
University Ghent
Harvard School of Public Health
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
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 IRSS
Principal Investigator: Nathalie De Cock, PhD University Ghent
Principal Investigator: Sheila Isanaka, Asst. Prof. Harvard T.H. Chan School of Public Health

Responsible Party: Department of Food Technology, Safety and Health, Prof. dr. Patrick Kolsteren, University Ghent
ClinicalTrials.gov Identifier: NCT03533712     History of Changes
Other Study ID Numbers: OPP1175213
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
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
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infant Nutrition Disorders
Nutrition Disorders
Malnutrition
Birth Weight
Body Weight
Signs and Symptoms
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs