Status:
COMPLETED
Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial
Lead Sponsor:
Liverpool School of Tropical Medicine
Collaborating Sponsors:
Institute of Tropical Medicine, Belgium
University of Manchester
Conditions:
Malaria
Eligibility:
FEMALE
15-24 years
Phase:
NA
Brief Summary
A randomized double-blind controlled trial will be carried out in which young, nulliparous (having never given birth) women will be randomly assigned to receive weekly supplementation with either iron...
Eligibility Criteria
Inclusion
- Female
- At least 15 and less than 25 years old at enrolment
- Never given birth
- Resident within the Demographic Surveillance System (DSS) area
- Willing to adhere to the study requirements (including weekly observed drug intake)
- Provision of written informed consent (if non emancipated minor by guardian/parent with minor's assent
Exclusion
- No menses for \>3 months and/or palpable uterus or positive pregnancy test if history unclear
- Concurrent enrolment in another study
- Intention to move out of the study area for more than 2 months within the next 18 months
- Any significant illness at the time of screening that requires hospitalization, including clinical signs of severe anaemia (conjunctival or mucosal pallor, tachycardia, respiratory distress)
- History or presence of major clinical disease likely to influence pregnancy outcome (sickle cell disease, diabetes mellitus, severe renal or heart disease, open tuberculosis, epilepsy)
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
1959 Patients enrolled
Trial Details
Trial ID
NCT01210040
Start Date
April 1 2011
End Date
January 1 2014
Last Update
March 19 2014
Active Locations (1)
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1
Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz
Bobo-Dioulasso, Burkina Faso, 01 B.P. 545