Status:
COMPLETED
Malaria and the Safety of Iron Supplements and Iron Fortification
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Iron Deficiency
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The primary study hypothesis of the investigators is that administration of an iron supplement between meals at a dose like that used in the Pemba trial (\~1 mg Fe/kg) during P. falciparum parasitemia...
Detailed Description
This research will determine the effects of acute infection with Plasmodium falciparum on the absorption, pharmacokinetics and metabolism of iron from iron supplements and other iron preparations in n...
Eligibility Criteria
Inclusion
- men or premenopausal woman, 18 to 50 years of age;
- peripheral blood positive for asexual forms of P. falciparum (this criterion not applicable to uninfected healthy control subjects);
- women not pregnant by self-report and not planning pregnancy;
- body weight \<65 kg.
Exclusion
- presence of severe or complicated malaria as defined by WHO criteria;
- clinical evidence of ill health or a history of chronic disorders;
- treatment for mental illness;
- imprisonment;
- institutionalization.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01156896
Start Date
July 1 2010
End Date
July 1 2014
Last Update
February 12 2015
Active Locations (1)
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1
Hospital for Tropical Diseases, Mahidol University
Bangkok, Thailand, 10400