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

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.

Conditions

• Malaria

Interventions

DIETARY_SUPPLEMENT

Folic Acid

2.8mg

DIETARY_SUPPLEMENT

Folic Acid and Iron

60mg Iron and 2.8mg Folic Acid

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest

  collaborator OTHER_GOV

• Centre Muraz

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Liverpool School of Tropical Medicine

  lead OTHER

Principal Investigators

• Bernard J BRABIN, Professor · Liverpool School of Tropical Medicine

• Sabine GIES, MD, MTropMed, PhD · Clinical Research Unit Nanoro (CRUN)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

24 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2013-11-30

Completion

2014-01-31

Countries

• Burkina Faso

Study Locations