A Phase 4 interventional study of iron in Malaria, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Kenya. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-29.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 4, Interventional, and Prevention
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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 470 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: iron
Dietary Supplement: iron
Daily supplementation with iron (60 mg) as ferrous sulphate
Maternal Plasmodium infection
Assessed by LDH- and HRP2-based dipstick test and PCR
Time frame: Parturition
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
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London School of Hygiene and Tropical Medicine