Long-term Iron Supplements and Malaria Risk in Early Pregnancy: a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Malaria
• Interventions: Dietary Supplement: Folic Acid; Dietary Supplement: Folic Acid and Iron

• Registration Number: NCT01210040
• Lead Sponsor: Liverpool School of Tropical Medicine

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 and folic acid or folic acid alone. Women will be followed-up weekly up to 18 months. Women who become pregnant will be followed-up until delivery. Malaria risk in both groups will be compared by assessing the prevalence of peripheral parasitaemia at the first antenatal clinic visit for pregnant women and at the end of the first malaria transmission season for non-pregnant women. The incidence of clinical malaria will be assessed by active and passive case detection throughout the follow-up period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-27
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Study Start: 2011-04
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1959

Inclusion Criteria

• 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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Folic Acid	Folic Acid	2.8mg of Folic Acid given weekly
Folic Acid and Iron	Folic Acid and Iron	2.8mg Folic Acid and 60mg Iron given weekly

Primary Outcome Measures

Name	Time	Method
Prevalence of peripheral parasitaemia at first antenatal clinic visit (13-16 weeks gestation)	Nov 2013	Completed

Secondary Outcome Measures

Name	Time	Method
a) In the pregnant cohort: Mean birth weight and prevalence of low birth weight (<2500g)	Jan 2014	Completed
a) In the non-pregnant cohort: Prevalence of anaemia after at least 18 months supplementation	Nov 2013	Completed
a) In the pregnant cohort: Incidence of clinical malaria during the first and subsequent trimesters	Jan 2014	Completed
a) In the pregnant cohort: Mean gestational age at delivery	Jan 2014	Completed
a) In the pregnant cohort: Prevalence of placental malaria	Jan 2014	Completed
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment	Nov 2013	Completed
a) In the non-pregnant cohort: Prevalence of iron deficiency at key study visits	Nov 2013	Completed
a) In the pregnant cohort: Incidence of adverse pregnancy outcomes	Jan 2014	Completed
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia during the first rainy season after at least six months of supplementation	Nov 2012	Completed
In the non-pregnant cohort: Prevalence of bacterial vaginosis at end assessment	Nov 2013	Completed
a) In the non-pregnant cohort: Prevalence of bacterial vaginosis at first antenatal visit	Nov 2013	Completed
a) In the pregnant cohort: Prevalence of anaemia at first antenatal clinic visit	Sept 2013	Completed
a) In the pregnant cohort: Prevalence of iron deficiency at first antenatal visit	Sept 2013	Completed
a) In the non-pregnant cohort: Incidence of gastrointestinal adverse events	Nov 2013	Completed
a) In the non-pregnant cohort: Incidence of clinical malaria	Nov 2013	Completed
a) In the non-pregnant cohort: Prevalence of iron deficiency after at least 18 months supplementation	Nov 2013	Completed
a) In the non-pregnant cohort: Adherence to supplementation	Nov 2013	Completed
a) In the non-pregnant cohort: Acceptability of weekly supplementation	June 2013	Completed
a) In the non-pregnant cohort: Prevalence of peripheral parasitaemia at end assessment	Nov 2013	Completed

Trial Locations

Locations (1)

Institute de Recherche en Sciences de la Sante, Direction Regionale de l'Ouest (IRSS-DRO) - / Centre Muraz; 🇧🇫 Bobo-Dioulasso 01, Burkina Faso