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Sponsors and Collaborators: |
Institute of Tropical Medicine, Belgium Nutrition Tiers Monde, Belgique Centre Muraz |
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Information provided by: | Institute of Tropical Medicine, Belgium |
ClinicalTrials.gov Identifier: | NCT00642408 |
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:
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 |
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Multiple Micronutrient Deficiencies During Pregnancy |
Dietary Supplement: Multiple micronutrient supplements (MMN) Dietary Supplement: IFA |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso |
Enrollment: | 1370 |
Study Start Date: | June 2003 |
Study Completion Date: | October 2006 |
Arms | Assigned Interventions |
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MMN: Experimental
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
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Dietary Supplement: Multiple micronutrient supplements (MMN)
Iron and folic acid: iron 60 mg and folic acid 400µg
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IFA: Active Comparator
iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).
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Dietary Supplement: IFA
Iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).
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Ages Eligible for Study: | 15 Years to 44 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:
Will be excluded from the study women :
Burkina Faso | |
Centre Muraz, 2054, Avenue Mamadou KONATE | |
Bobo-Dioulasso, Burkina Faso, BP 390 |
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) |
Responsible Party: | Institute of Tropical Medicine, Belgium ( Prof. Patrick Kolsteren, head of the Nutrition and Child Health Unit ) |
Study ID Numbers: | IUGR |
Study First Received: | March 13, 2008 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00642408 History of Changes |
Health Authority: | Burkina Faso: Ministry of Health |
Folic Acid Fetal Diseases Pregnancy Complications Growth Disorders |
Trace Elements Micronutrients Iron Fetal Growth Retardation |
Fetal Diseases Pathologic Processes Pregnancy Complications Growth Substances Physiological Effects of Drugs |
Growth Disorders Trace Elements Micronutrients Pharmacologic Actions Fetal Growth Retardation |