Prenatal Iron and Malaria Study (PIMAL)
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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 |
- Maternal Plasmodium infection [ Time Frame: Parturition ] [ Designated as safety issue: Yes ]Assessed by LDH- and HRP2-based dipstick test and PCR
- 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 ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | September 2012 (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 |
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| Contact: Martin N Mwangi, MSc | +254 734 018863 | martinndegwa.mwangi@wur.nl |
| Contact: Pauline EA Andang'o, PhD | +254 728 485729 | paulango@hotmail.com |
| Kenya | |
| University of Nairobi | Recruiting |
| Nairobi, Kenya | |
| Contact: Alice Mbogani-Mwangi, PhD +254 733 826186 amwangi@uonbi.ac.ke | |
| Sub-Investigator: Alice Mbogani-Mwangi, PhD | |
| 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: | February 1, 2012 |
| 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 May 19, 2013