Clinical Trials Directory

Trials / Completed

CompletedNCT01108939

Study of Iron Absorption and Utilization in Asymptomatic Malaria

The Effect of Asymptomatic Malaria on Iron Absorption and Utilization From a Sorghum-based Meal in Adult Women in Benin

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Swiss Federal Institute of Technology · Academic / Other
Sex
Female
Age
16 Years – 35 Years
Healthy volunteers
Not accepted

Summary

Anemia is still a main public health problem in sub-Saharan Africa. Anemic women have an increased maternal and perinatal mortality and anemic adults have diminished work capacity. In sub-Saharan Africa, the etiology of anemia is multifactoral; the major causes are low dietary bioavailability and chronic parasitic infections such as malaria. These causes are likely to interact because infection and infection-associated inflammation may impair the utilization and absorption of iron. Therefore, the control of parasite infections may be important to improve iron bioavailability from foods. Malaria infections are endemic in northern Benin. To investigate the contribution of asymptomatic malaria (a positive blood smear for malarial parasites but without clinical symptoms of fever, headache or malaise) to anemia, we are planning a human iron absorption study in Benin. We will recruit adults with asymptomatic malaria infection. The iron absorption and utilization of the study subjects will be studied while infected, then they will be treated to clear their infections, and then iron absorption and utilization will be restudied. Iron absorption will be determined by incorporation of labeled iron into erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable isotope technique). Subjects will be men and non-pregnant, non-breastfeeding women with a body weight \< 65 kg and between the age of 18 - 30 years. The results of this study will provide important information on the influence of malaria infections on iron absorption and utilization in humans. The study will provide insight into the potential necessity of malaria control to ensure iron bioavailability from foods in developing countries.

Conditions

Interventions

TypeNameDescription
DRUGAntimalarial treatment
OTHERObservation

Timeline

Start date
2009-02-01
Primary completion
2009-09-01
Completion
2010-04-01
First posted
2010-04-22
Last updated
2013-06-07

Locations

1 site across 1 country: Benin

Source: ClinicalTrials.gov record NCT01108939. Inclusion in this directory is not an endorsement.