Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso (MISAME2)
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Purpose
Low birth weight (LBW; birth weight<2,500g) is the most important determinant of mortality and morbidity in the neonatal period. It is also a very important factor in predicting nutritional status, health and development in childhood. It even influences health in adult life, contributing to the vicious cycle of disease and poverty. The high rate LBW in DCs represents therefore a major public health problem. Maternal chronic energy deficiency is assumed to be a major determinant of the problem in these countries along with prenatal micronutrient deficiencies. A large body of recent evidence points out that multiple micronutrient supplementation as such has only a modest beneficial effect on fetal growth. Therefore, it is expected that providing these multiple micronutrients in a food supplement covering energy requirement needs of pregnant women will have an effect of public health importance on children's health.
This study has the objective of improving children's health by improving birth outcome and fetal growth through the provision of a food supplement enriched in multimicronutrients during pregnancy.
This research includes 2 constituents:
- a pilot phase during which dietary behavior of pregnant women is assessed as a component for optimal fetal growth
- a randomized, placebo-controlled trial, including 1300 pregnant women aimed at testing 2 hypotheses: supplementing pregnant women with a food supplement containing a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy.
The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz, which plays a leader role in research and services providing at the district level and in policy recommendations at the national level. This will ensure that the study findings are incorporated into on-going district programs with possible replication at the national level. The research lasts from February 2006 to August 2009.
| Condition | Intervention | Phase |
|---|---|---|
|
Intrauterine Growth Retardation Low Birth Weight |
Dietary Supplement: UNIMMAP - multiple micronutrients Dietary Supplement: Food supplement enriched with multiple micronutrients |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso |
- Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
- Mortality, morbidity and growth during the first year of life [ Time Frame: Monthly during infancy ] [ Designated as safety issue: Yes ]
- Placental weight; LBW; SGA; thoracic circumference; head circumference; mid-upper arm circumference; hemoglobin concentration in mothers and in newborns; soluble sTfR in cord blood as an iron status indicator; preterm birth; stillbirth; perinatal death [ Time Frame: Different depending on mother and child ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1302 |
| Study Start Date: | February 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Food supplement (FS)
Recipe of food supplement: 33% peanut butter, 32% soy flour, 15% vegetable oil, 20% sugar, UNIMMAP in powdered form Nutritional composition (per dose of 72g) Energy 1.56 MJ, protein 14.7 g, vitamin A 881 µg, vitamin E 13 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 21 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 461 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg
|
Dietary Supplement: Food supplement enriched with multiple micronutrients
One dose of 72g per day during whole pregnancy Recipe of food supplement: 33% peanut butter, 32% soy flour, 15% vegetable oil, 20% sugar, UNIMMAP in powdered form Nutritional composition (per dose of 72g) Energy 1.56 MJ, protein 14.7 g, vitamin A 881 µg, vitamin E 13 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 21 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 461 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg Other Name: Lipid based nutritional supplement (LNS)
|
|
Active Comparator: UNIMMAP
UNIMMAPin tablet form: vitamin A 800µg, vitamin E 10 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 18 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 400 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg
|
Dietary Supplement: UNIMMAP - multiple micronutrients
Daily supplementation of one UNIMMAP tablet multiple micronutrient supplements (MMN): UNIMMAP: vitamin A 800µg, vitamin E 10 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 18 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 400 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg |
Show Detailed Description Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All the women of child-bearing age (15-44 years) living in the study area (4 100) will be visited monthly to assess early pregnancy and will be invited to participate in the trial.
Exclusion Criteria:
- planning to move outside the district within the 2 years following the start of the trial.
- regularly using a contraceptive method.
- already pregnant at the start of the trial.
Contacts and Locations| Burkina Faso | |
| Centre Muraz, 2054, Avenue Mamadou KONATE | |
| Bobo-Dioulasso, Burkina Faso | |
| Principal Investigator: | Lieven Huybregts, MSc | University Ghent, Belgium |
| Study Chair: | Patrick Kolsteren, PhD | Institute of Tropical Medicine, Belgium; Ghent University, Belgium |
| Principal Investigator: | Dominqiue Roberfroid, MD | Institute of Tropical Medicine, Belgium |
| Principal Investigator: | Nicolas Meda, PhD | Centre Muraz |
More Information
Additional Information:
No publications provided by Institute of Tropical Medicine, Belgium
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Patrick Kolsteren, head of Child Health and Nutrition Unit, Institute of Tropical Medicine, Belgium |
| ClinicalTrials.gov Identifier: | NCT00909974 History of Changes |
| Other Study ID Numbers: | ZEIN2004PR298 |
| Study First Received: | May 28, 2009 |
| Last Updated: | September 12, 2010 |
| Health Authority: | Burkina Faso: Ministry of Health |
Keywords provided by Institute of Tropical Medicine, Belgium:
|
multiple micronutrients energy deficiency |
Additional relevant MeSH terms:
|
Birth Weight Fetal Growth Retardation Body Weight Signs and Symptoms Fetal Diseases Pregnancy Complications Growth Disorders Pathologic Processes |
Vitamin B 12 Micronutrients Trace Elements Vitamin B Complex Vitamins Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013