Prenatal Iron and Malaria Study

London School of Hygiene and Tropical Medicine470 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

470

Conditions

Malaria

Interventions

ironDIETARY_SUPPLEMENT

Daily supplementation with iron (60 mg) as ferrous sulphate

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Nairobi

Nairobi, Kenya

Outcomes

Primary Outcomes

Maternal Plasmodium infection

Assessed by LDH- and HRP2-based dipstick test and PCR

Time frame: Parturition

Secondary Outcomes

Serum non-transferrin bound iron concentration

Time frame: 3 h after ingestion of first supplement with either iron or placebo

Neonatal iron stores

Assessed by plasma ferritin concentration, restricted to infants without inflammation

Time frame: At 1 month of age

Maternal iron status

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.

Time frame: At 1 month after delivery

Maternal intestinal pathogens

Time frame: At 1 month after delivery

Data from ClinicalTrials.gov

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