Prenatal Iron and Malaria Study (PIMAL)

This study has been completed.
Sponsor:
Collaborators:
University of Nairobi
Wageningen University
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01308112
First received: March 2, 2011
Last updated: May 28, 2013
Last verified: May 2013

March 2, 2011
May 28, 2013
October 2011
April 2013   (final data collection date for primary outcome measure)
Maternal Plasmodium infection [ Time Frame: Parturition ] [ Designated as safety issue: Yes ]
Assessed by LDH- and HRP2-based dipstick test and PCR
Same as current
Complete list of historical versions of study NCT01308112 on ClinicalTrials.gov Archive Site
  • Serum non-transferrin bound iron concentration [ Time Frame: 3 h after ingestion of first supplement with either iron or placebo ] [ Designated as safety issue: Yes ]
  • Neonatal iron stores [ Time Frame: At 1 month of age ] [ Designated as safety issue: No ]
    Assessed by plasma ferritin concentration, restricted to infants without inflammation
  • Maternal iron status [ Time Frame: At 1 month after delivery ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 1 month after delivery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prenatal Iron and Malaria Study
A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Malaria
Dietary Supplement: iron
Daily supplementation with iron (60 mg) as ferrous sulphate
  • Experimental: Supplemental iron
    Intervention: Dietary Supplement: iron
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: iron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
470
May 2013
April 2013   (final data collection date for primary outcome measure)

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.
Female
15 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01308112
LSHTM-5664
Yes
London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • University of Nairobi
  • Wageningen University
Principal Investigator: Hans Verhoef, PhD London School of Hygiene and Tropical Medicine, UK
London School of Hygiene and Tropical Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP