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
  Purpose

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.


Condition Intervention Phase
Malaria
Dietary Supplement: iron
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Maternal Plasmodium infection [ Time Frame: Parturition ] [ Designated as safety issue: Yes ]
    Assessed by LDH- and HRP2-based dipstick test and PCR


Secondary Outcome Measures:
  • 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 ]

Enrollment: 470
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplemental iron Dietary Supplement: iron
Daily supplementation with iron (60 mg) as ferrous sulphate
Placebo Comparator: Placebo Dietary Supplement: iron
Daily supplementation with iron (60 mg) as ferrous sulphate

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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308112

Locations
Kenya
University of Nairobi
Nairobi, Kenya
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University of Nairobi
Wageningen University
Investigators
Principal Investigator: Hans Verhoef, PhD London School of Hygiene and Tropical Medicine, UK
  More Information

No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01308112     History of Changes
Other Study ID Numbers: LSHTM-5664
Study First Received: March 2, 2011
Last Updated: May 28, 2013
Health Authority: Kenya: Ethical Review Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
Iron
Plasmodium
Malaria
Pregnancy
Kenya

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014