Prenatal Iron and Malaria Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Supplemental iron

Group Type EXPERIMENTAL

iron

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation with iron (60 mg) as ferrous sulphate

Placebo

Group Type PLACEBO_COMPARATOR

iron

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation with iron (60 mg) as ferrous sulphate

Interventions

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iron

Daily supplementation with iron (60 mg) as ferrous sulphate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes