Prenatal Iron and Malaria Study

Phase 4

Completed

• Conditions: Malaria
• Interventions: Dietary Supplement: iron

• Registration Number: NCT01308112
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-03
• Study Start: 2011-10
• Primary Completion: 2013-04
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 470

Inclusion Criteria

• Women aged 15-45 years resident in the predefined study area
• Pregnant, with gestational age <23 weeks

Exclusion Criteria

• Failure to provide a blood sample
• Initial haemoglobin concentration <90 g/L
• Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes
• Obstetric history suggestive of eclampsia or pre-eclampsia
• Obvious mental retardation or metabolic disorder;
• No written consent
• Carrying multiples
• Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter
• Woman planning to deliver outside the research clinic.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplemental iron	iron	-
Placebo	iron	-

Primary Outcome Measures

Name	Time	Method
Maternal Plasmodium infection	Parturition	Assessed by LDH- and HRP2-based dipstick test and PCR

Secondary Outcome Measures

Name	Time	Method
Serum non-transferrin bound iron concentration	3 h after ingestion of first supplement with either iron or placebo
Neonatal iron stores	At 1 month of age	Assessed by plasma ferritin concentration, restricted to infants without inflammation
Maternal iron status	At 1 month after delivery	To be assessed by haemoglobin concentrations, prevalence of iron deficiency anaemia (plasma ferritin concentration \<12 µg/L) and iron stores (ratio of ferritin:transferrin receptor concentrations); indicators based on ferritin and/or transferrin receptor will be restricted to those without inflammation.
Maternal intestinal pathogens	At 1 month after delivery

Trial Locations

Locations (1)

University of Nairobi; 🇰🇪 Nairobi, Kenya