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Sponsors and Collaborators: |
Institute of Tropical Medicine, Belgium Departments of Parasitology and Public Health, ITM, Antwerp, Belgium Centre Muraz Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso |
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Information provided by: | Institute of Tropical Medicine, Belgium |
ClinicalTrials.gov Identifier: | NCT00680732 |
Our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. This study was carried out !in the same population recruited for the IUGR study (NCT00642408).
Condition | Intervention | Phase |
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Malaria Malaria in Pregnancy |
Dietary Supplement: Multiple micronutrients supplements (MMS) Dietary Supplement: Iron and folic acid (IFA) Drug: Chloroquine (CQ) Drug: Sulphadoxyne-pyrimethamine (SP) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso: the Malaria Component |
Enrollment: | 1370 |
Study Start Date: | June 2003 |
Study Completion Date: | October 2006 |
Arms | Assigned Interventions |
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A1: Experimental
Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)
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Dietary Supplement: Multiple micronutrients supplements (MMS)
Vitamin A 800 mcg; vitamin E 10 mg; vitamin D 5 mcg; vitamin B1 1.4 mg; vitamin B2 1.4 mg;niacin 18 mg; vitamin B6 1.9 mg; vitamin B12 2.6 mcg; folic acid 400 mcg; vitamin C 70 mg; iron 30 mg; zinc 15 mg; copper 2 mg; selenium 65 mcg; iodine 150 mcg
Drug: Chloroquine (CQ)
Tablets 100 mg of chloroquine base
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A2: Experimental
Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)
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Dietary Supplement: Multiple micronutrients supplements (MMS)
Vitamin A 800 mcg; vitamin E 10 mg; vitamin D 5 mcg; vitamin B1 1.4 mg; vitamin B2 1.4 mg;niacin 18 mg; vitamin B6 1.9 mg; vitamin B12 2.6 mcg; folic acid 400 mcg; vitamin C 70 mg; iron 30 mg; zinc 15 mg; copper 2 mg; selenium 65 mcg; iodine 150 mcg
Drug: Sulphadoxyne-pyrimethamine (SP)
Tablets
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B1: Experimental
Iron and folic acid (IFA) and weekly chloroquine (CQ)
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Dietary Supplement: Iron and folic acid (IFA)
Iron 60 mg and folic acid 400 mcg
Drug: Chloroquine (CQ)
Tablets 100 mg of chloroquine base
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B2: Experimental
Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)
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Dietary Supplement: Iron and folic acid (IFA)
Iron 60 mg and folic acid 400 mcg
Drug: Sulphadoxyne-pyrimethamine (SP)
Tablets
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A research project aiming at investigating the impact of multivitamin-mineral supplementation (MMS) during pregnancy on intra-uterin growth retardation was carried out in the Hounde district, an area not far from the Centre Muraz located in Bobo Dioulasso, and where malaria is endemic. Malaria during pregnancy increases the risk of low birth weight, infant mortality and morbidity during the first year of life by inducing growth retardation, prematurity and infant anaemia.
The administration of an antimalarial drug during pregnancy has a beneficial effect on the mother and child's health by preventing malaria infection and its consequences. However, most studies have been carried out during the second or third trimester of pregnancy: the effect of malaria infection during the first trimester on the mother's and child's health is unknown. It has been reported that even one single infection may have a significant impact on the outcome of pregnancy: if it is true, then early chemoprophylaxis may have an additional advantage.
An alternative approach is the administration of intermittent presumptive treatment, which may achieve equal efficacy to continuos chemoprophylaxis; however, no studies compared effective weekly malaria chemoprophylaxis with effective intermittent presumptive treatment. Moreover, the incidence of malaria clinical episodes during SP intermittent preventive treatment has never been investigated.
Therefore, this open label, factorial study was carried out in the same women recruited for the IUGR nutritional study (NCT00642408). Women receiving multiple micronutrients supplements (MMS) or dietary supplements (IFA) were further randomised in 2 groups: CQ weekly chemoprophylaxis or SP intermittent preventive treatment. The administration of treatment was directly observed.
Ages Eligible for Study: | 15 Years to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Burkina Faso | |
Centre Muraz | |
Bobo-Dioulasso, Burkina Faso, BP 390 |
Principal Investigator: | Marie Claire Henry, MD | Centre Muraz |
Responsible Party: | ITM ( Prof. Umberto D'Alessandro, Head of the Parasitology Department ) |
Study ID Numbers: | IUGR Malaria |
Study First Received: | April 23, 2008 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00680732 |
Health Authority: | Burkina Faso: Ministry of Health |
Malaria Pregnancy Prevention Chloroquine |
Sulphadoxine pyrimethamine Maternal anaemia Birth weight Foetal anaemia |
Pyrimethamine Pregnancy Complications Malaria Copper Vitamin B 6 Body Weight Tocopherols Nicotinic Acids Selenium Fetal Diseases Retinol palmitate Zinc Iodine Parasitic Diseases Birth Weight |
Protozoan Infections Sulfadoxine-pyrimethamine Tocopherol acetate Hydroxocobalamin Thiamine Anemia Ergocalciferols Chloroquine Vitamin B 12 Sulfadoxine Alpha-Tocopherol Folic Acid Vitamin E Vitamin D Riboflavin |
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Antimalarials Antiparasitic Agents Pathologic Processes Sensory System Agents Therapeutic Uses Vitamins Anti-Inflammatory Agents, Non-Steroidal Analgesics Amebicides |
Micronutrients Antinematodal Agents Vitamin B Complex Hematinics Coccidiosis Filaricides Growth Substances Enzyme Inhibitors Anthelmintics Folic Acid Antagonists Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |