NCT01210040

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

Malaria Risk Prior to and During Early Pregnancy in Nulliparous Women Receiving Long-term Weekly Iron and Folic Acid Supplementation (WIFS): a Non-inferiority Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,959 (actual)
• Sponsor: Liverpool School of Tropical Medicine · Academic / Other
• Sex: Female
• Age: 15 Years – 24 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Folic Acid	2.8mg
DIETARY_SUPPLEMENT	Folic Acid and Iron	60mg Iron and 2.8mg Folic Acid

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-11-01
• Completion: 2014-01-01
• First posted: 2010-09-28
• Last updated: 2014-03-19

Locations

1 site across 1 country: Burkina Faso