Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso

Summary

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.

Conditions

• Intrauterine Growth Retardation
• Low Birth Weight

Interventions

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

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

Sponsors & Collaborators

• University Ghent

  collaborator OTHER

• Flemish Interuniversity Council (VLIR)

  collaborator NETWORK

• Nutrition Third World, Belgium

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  lead OTHER

Principal Investigators

• Lieven Huybregts, MSc · University Ghent, Belgium

• Patrick Kolsteren, PhD · Institute of Tropical Medicine, Belgium; Ghent University, Belgium

• Dominqiue Roberfroid, MD · Institute of Tropical Medicine, Belgium

• Nicolas Meda, PhD · Centre Muraz

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-02-28

Primary Completion

2008-12-31

Completion

2008-12-31

Countries

• Burkina Faso

Study Locations