University of Nairobi
Nairobi, Kenya
NCT Number: NCT01308112
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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Notify Me15 year–45 year
Female
Interventional
Phase 4
Nairobi, Kenya
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily supplementation with iron (60 mg) as ferrous sulphate
Time frame: Parturition
Assessed by LDH- and HRP2-based dipstick test and PCR
Time frame: 3 h after ingestion of first supplement with either iron or placebo
Time frame: At 1 month of age
Assessed by plasma ferritin concentration, restricted to infants without inflammation
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.
Time frame: At 1 month after delivery
London School of Hygiene and Tropical Medicine
Other
A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women
Acronym: PIMAL
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