Prenatal Iron and Malaria Study (PIMAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01308112
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : May 29, 2013
University of Nairobi
Wageningen University
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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.

Condition or disease Intervention/treatment Phase
Malaria Dietary Supplement: iron Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women
Study Start Date : October 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Malaria
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Maternal Plasmodium infection [ Time Frame: Parturition ]
    Assessed by LDH- and HRP2-based dipstick test and PCR

Secondary Outcome Measures :
  1. Serum non-transferrin bound iron concentration [ Time Frame: 3 h after ingestion of first supplement with either iron or placebo ]
  2. Neonatal iron stores [ Time Frame: At 1 month of age ]
    Assessed by plasma ferritin concentration, restricted to infants without inflammation

  3. Maternal iron status [ Time Frame: 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.

  4. Maternal intestinal pathogens [ Time Frame: At 1 month after delivery ]

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01308112

University of Nairobi
Nairobi, Kenya
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine Identifier: NCT01308112     History of Changes
Other Study ID Numbers: LSHTM-5664
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by London School of Hygiene and Tropical Medicine:

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs