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Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso

This study has been completed.
Sponsor:
Collaborators:
Nutrition Tiers Monde, Belgique
Centre Muraz
Information provided by:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT00642408
First received: March 13, 2008
Last updated: September 12, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Multiple Micronutrient Deficiencies During Pregnancy
Dietary Supplement: Multiple micronutrient supplements (MMN)
Dietary Supplement: IFA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • Weight, length and Rohrer index at birth, and gestational duration in single 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1370
Study Start Date: June 2003
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MMN
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: Multiple micronutrient supplements (MMN)
Iron and folic acid: iron 60 mg and folic acid 400µg
Active Comparator: IFA
iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).
Dietary Supplement: IFA
Iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

Will be excluded from the study women :

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642408

Locations
Burkina Faso
Centre Muraz, 2054, Avenue Mamadou KONATE
Bobo-Dioulasso, Burkina Faso, BP 390
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Nutrition Tiers Monde, Belgique
Centre Muraz
Investigators
Principal Investigator: Dominique Roberfroid, MD ITM Antwerp
Principal Investigator: Nicolas Meda, MD Head of the Epidemiology Unit in Centre Muraz
Study Chair: Patrick Kolsteren, MD head of the Nutrition and Child Health Unit in the Institute of Tropical Medicine (ITM, Antwerp, Belgium)
  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 the Nutrition and Child Health Unit, Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT00642408     History of Changes
Other Study ID Numbers: IUGR
Study First Received: March 13, 2008
Last Updated: September 12, 2010
Health Authority: Burkina Faso: Ministry of Health

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Growth Disorders
Pathologic Processes
Pregnancy Complications
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014