Prenatal Iron and Malaria Study

Malaria Clinical Trial

— PIMAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308112
• Other study ID #: LSHTM-5664
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2011
• Last updated: May 28, 2013
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Dietary Supplement:
• iron
Daily supplementation with iron (60 mg) as ferrous sulphate

Locations

Country	Name	City	State
Kenya	University of Nairobi	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	University of Nairobi, Wageningen University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Plasmodium infection	Assessed by LDH- and HRP2-based dipstick test and PCR	Parturition	Yes
Secondary	Serum non-transferrin bound iron concentration		3 h after ingestion of first supplement with either iron or placebo	Yes
Secondary	Neonatal iron stores	Assessed by plasma ferritin concentration, restricted to infants without inflammation	At 1 month of age	No
Secondary	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	No
Secondary	Maternal intestinal pathogens		At 1 month after delivery	No