Prenatal Iron and Malaria Study (PIMAL)

London School of Hygiene and Tropical Medicine

Status and phase

Completed

Phase 4

Conditions

Malaria

Treatments

Dietary Supplement: iron

Study type

Interventional

Funder types

Other

Identifiers

NCT01308112

LSHTM-5664

Details and patient eligibility

About

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.

Full 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.

Enrollment

470 patients

Sex

Female

Ages

15 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.