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Completed

NCT Number: NCT01308112

Prenatal Iron and Malaria Study

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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Key information

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Nairobi

Nairobi, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iron

Dietary Supplement

Daily supplementation with iron (60 mg) as ferrous sulphate

Primary outcomes

  1. Maternal Plasmodium infection

    Time frame: Parturition

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

Secondary outcomes

  1. Serum non-transferrin bound iron concentration

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

  2. Neonatal iron stores

    Time frame: At 1 month of age

    Assessed by plasma ferritin concentration, restricted to infants without inflammation

  3. Maternal iron status

    Time frame: 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.

  4. Maternal intestinal pathogens

    Time frame: At 1 month after delivery

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • University of Nairobi
  • Wageningen University

Registry information

Official study title

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

Acronym: PIMAL

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2011
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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