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Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component

NCT ID: NCT00680732

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Malaria Malaria in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A1

Multiple micronutrients supplements (MMS) and weekly chloroquine (CQ)

Group Type EXPERIMENTAL

Multiple micronutrients supplements (MMS)

Intervention Type DIETARY_SUPPLEMENT

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

Chloroquine (CQ)

Intervention Type DRUG

Tablets 100 mg of chloroquine base

A2

Multiple micronutrients supplements (MMS) and intermittent suplphadoxyne-pyrimethamine (SP)

Group Type EXPERIMENTAL

Multiple micronutrients supplements (MMS)

Intervention Type DIETARY_SUPPLEMENT

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

Sulphadoxyne-pyrimethamine (SP)

Intervention Type DRUG

Tablets

B1

Iron and folic acid (IFA) and weekly chloroquine (CQ)

Group Type EXPERIMENTAL

Iron and folic acid (IFA)

Intervention Type DIETARY_SUPPLEMENT

Iron 60 mg and folic acid 400 mcg

Chloroquine (CQ)

Intervention Type DRUG

Tablets 100 mg of chloroquine base

B2

Iron and folic acid (IFA) and intermittent sulphadoxyne-pyrimethamine (SP)

Group Type EXPERIMENTAL

Iron and folic acid (IFA)

Intervention Type DIETARY_SUPPLEMENT

Iron 60 mg and folic acid 400 mcg

Sulphadoxyne-pyrimethamine (SP)

Intervention Type DRUG

Tablets

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Iron and folic acid (IFA)

Iron 60 mg and folic acid 400 mcg

Intervention Type DIETARY_SUPPLEMENT

Chloroquine (CQ)

Tablets 100 mg of chloroquine base

Intervention Type DRUG

Sulphadoxyne-pyrimethamine (SP)

Tablets

Intervention Type DRUG

Other Intervention Names

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UNIMMAP Fansidar

Eligibility Criteria

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Inclusion Criteria

* 15 to 44 years
* females
* living in the study area

Exclusion Criteria

* planning to move outside the district within two years
* regularly using a contraceptive methods
* already pregnant at the start of the trial
Minimum Eligible Age

15 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Departments of Parasitology and Public Health, ITM, Antwerp, Belgium

UNKNOWN

Sponsor Role collaborator

Centre Muraz

OTHER

Sponsor Role collaborator

Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso

UNKNOWN

Sponsor Role collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role lead

Responsible Party

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ITM

Principal Investigators

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Marie Claire Henry, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Muraz

Locations

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Centre Muraz

Bobo-Dioulasso, , Burkina Faso

Site Status

Countries

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Burkina Faso

Other Identifiers

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IUGR Malaria

Identifier Type: -

Identifier Source: org_study_id