Prenatal Iron and Malaria Study

Study Overview
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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.

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.

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

Conditions
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Malaria

Intervention / Treatment
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* Dietary Supplement: iron


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplemental iron<br> | Dietary Supplement: iron<br>* Daily supplementation with iron (60 mg) as ferrous sulphate<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: iron<br>* Daily supplementation with iron (60 mg) as ferrous sulphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Plasmodium infection | Assessed by LDH- and HRP2-based dipstick test and PCR | Parturition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum non-transferrin bound iron concentration |  | 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 | 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. | At 1 month after delivery | 
| Maternal intestinal pathogens |  | At 1 month after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron, Plasmodium, Malaria, Pregnancy, Kenya