Low Birth Weight Clinical Trial
— MISAME2Official title:
Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso
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:
1. a pilot phase during which dietary behavior of pregnant women is assessed as a
component for optimal fetal growth
2. 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.
Status | Completed |
Enrollment | 1302 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Centre Muraz, 2054, Avenue Mamadou KONATE | Bobo-Dioulasso |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium | Flemish Interuniversity Council (VLIR), Nutrition Third World, Belgium, University Ghent |
Burkina Faso,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. | At birth | Yes | |
Primary | Mortality, morbidity and growth during the first year of life | Monthly during infancy | Yes | |
Secondary | 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 | Different depending on mother and child | Yes |
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