Malaria
Conditions
Keywords
Iron, Plasmodium, Malaria, Pregnancy, Kenya
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTiron
Daily supplementation with iron (60 mg) as ferrous sulphate
Sponsors
University of Nairobi
Wageningen University
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Plasmodium infection | Parturition | Assessed by LDH- and HRP2-based dipstick test and PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum non-transferrin bound iron concentration | 3 h after ingestion of first supplement with either iron or placebo | — |
| Neonatal iron stores | At 1 month of age | Assessed by plasma ferritin concentration, restricted to infants without inflammation |
| Maternal iron status | 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. |
| Maternal intestinal pathogens | At 1 month after delivery | — |
Countries
Kenya
Outcome results
None listed