Clinical trial NCT01308112: Prenatal Iron and Malaria Study
Official title: A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: Iron
Plasmodium
Malaria
Pregnancy
Kenya
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: University of Nairobi
name: Wageningen University
First posted: 2011-03-03
Enrollment: 470
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: Maternal Plasmodium infection
timeFrame: Parturition
Secondary outcomes:
measure: Serum non-transferrin bound iron concentration
timeFrame: 3 h after ingestion of first supplement with either iron or placebo
measure: Neonatal iron stores
timeFrame: At 1 month of age
measure: Maternal iron status
timeFrame: At 1 month after delivery
measure: Maternal intestinal pathogens
timeFrame: At 1 month after delivery
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: University of Nairobi
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Hans Verhoef, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mwangi MN, Roth JM, Smit MR, Trijsburg L, Mwangi AM, Demir AY, Wielders JP, Mens PF, Verweij JJ, Cox SE, Prentice AM, Brouwer ID, Savelkoul HF, Andang'o PE, Verhoef H. Effect of Daily Antenatal Iron Supplementation on Plasmodium Infection in Kenyan Women: A Randomized Clinical Trial. JAMA. 2015 Sep 8;314(10):1009-20. doi: 10.1001/jama.2015.9496.
citation: Mwangi MN, Maskey S, Andang o PE, Shinali NK, Roth JM, Trijsburg L, Mwangi AM, Zuilhof H, van Lagen B, Savelkoul HF, Demir AY, Verhoef H. Diagnostic utility of zinc protoporphyrin to detect iron deficiency in Kenyan pregnant women. BMC Med. 2014 Nov 26;12:229. doi: 10.1186/s12916-014-0229-8.