NCT01308112

Prenatal Iron and Malaria Study

A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.

Detailed description

As per recommendations by the World Health Organization (WHO), iron supplementation in children should be restricted in malaria-endemic areas because of concerns that it can lead to an increased burden of malaria. Universal iron supplementation continues to be recommended, however, for women during pregnancy and 3 months postpartum. Observational studies have shown that iron deficiency in parturient women is associated with a marked reduction in the prevalence and density of malarial parasites in the placenta. Plasmodium infections in pregnant women have devastating effects on the foetus and neonate, causing low birth weight, intrauterine growth retardation, preterm delivery, spontaneous abortion, stillbirth and neonatal mortality. Based on our previous work, the Kenyan government is currently drafting legislation for mandatory iron fortification of industrially milled flour. Implementation of the new fortification policy means that pregnant women will receive iron through a combination of fortified foods and supplementation. The investigators are concerned about the safety of the high iron intake resulting from such a policy.

Conditions

• Malaria

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	iron	Daily supplementation with iron (60 mg) as ferrous sulphate

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2011-03-03
• Last updated: 2013-05-29

Locations

1 site across 1 country: Kenya