Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso

Summary

Intrauterine Growth Retardation 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 IUGR in DCs represents therefore a major public health problem. Maternal malnutrition is usually assumed to be a major determinant of the problem in these countries. An increasing amount of evidence points to the potential role played by micronutrient deficiencies during pregnancy. The adverse effect on birthweight of maternal iron deficiency anaemia, lack of zinc and lack of iodine have been documented. A similar effect is suspected for Vitamin A, Magnesium, Calcium, Copper,Thiamine, Pyridoxine and Folic acid. It seems that not one specific deficiency alone is responsible for this adverse effect, but rather a combination of them. Therefore, it is expected that covering needs of pregnant women by a multivitamin-mineral supplement will have an effect of public health importance on children's health.

This study has the objective of improving children's health by preventing intrauterine growth retardation through the provision of multivitamin-mineral supplements during pregnancy.

This research includes 2 constituents:

1. a pilot phase during which socio-anthropological, nutritional and epidemiological aspects of IUGR will be assessed through qualitative and epidemiological methods.
2. a double-blind, randomised, placebo-controlled trial, including 1215 pregnant women aimed at testing 3 hypotheses: supplementing pregnant women with a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy; covering nutritional needs of lactating women with a multivitamin-minerals mix during 3 months after delivery will improve health and growth of infants.

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 programmes with possible replication at the national level. The research lasts from June 2003 to October 2006.

Conditions

• Multiple Micronutrient Deficiencies During Pregnancy

Interventions

DIETARY_SUPPLEMENT

Multiple micronutrient supplements (MMN)

Iron and folic acid: iron 60 mg and folic acid 400µg

DIETARY_SUPPLEMENT

IFA

Iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).

Sponsors & Collaborators

• Nutrition Tiers Monde, Belgique

  collaborator UNKNOWN

• Centre Muraz

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  lead OTHER

Principal Investigators

• Dominique Roberfroid, MD · ITM Antwerp

• Nicolas Meda, MD · Head of the Epidemiology Unit in Centre Muraz

• Patrick Kolsteren, MD · head of the Nutrition and Child Health Unit in the Institute of Tropical Medicine (ITM, Antwerp, Belgium)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-06-30

Primary Completion

2006-10-31

Completion

2006-10-31

Countries

• Burkina Faso

Study Locations