Prenatal Iron and Malaria Study

NCT01308112 | Completed Phase 4 DMC

• 1 other identifier: LSHTM-5664
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Iron; Plasmodium; Malaria; Pregnancy; Kenya

Outcome Measures

Primary Outcomes (1)

• Maternal Plasmodium infection

  Assessed by LDH- and HRP2-based dipstick test and PCR

  Parturition

Secondary Outcomes (4)

• Serum non-transferrin bound iron concentration

  3 h after ingestion of first supplement with either iron or placebo

• Neonatal iron stores

  At 1 month of age

• Maternal iron status

  At 1 month after delivery

• Maternal intestinal pathogens

  At 1 month after delivery

Study Arms (2)

Supplemental iron

EXPERIMENTAL

Dietary Supplement: iron

Placebo

PLACEBO COMPARATOR

Dietary Supplement: iron

Interventions

iron DIETARY_SUPPLEMENT

Daily supplementation with iron (60 mg) as ferrous sulphate

Placebo; Supplemental iron

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged 15-45 years resident in the predefined study area
• Pregnant, with gestational age \<23 weeks

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University of Nairobi: collaborator
• Wageningen University: collaborator

Study Sites (1)

University of Nairobi

Nairobi, Kenya

Location

Related Publications (2)

• 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.

  PMID: 26348751 DERIVED

• 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.

  PMID: 25428714 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Iron

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Hans Verhoef, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 3, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

KE (1)