Study of Iron Absorption and Utilization in Asymptomatic Malaria

Malaria, Falciparum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108939
• Other study ID #: Fe_Malaria_Benin
• Status: Completed
• Phase: Phase 0
• First received: April 21, 2010
• Last updated: June 6, 2013
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Benin: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age 18-35 y

• Body weight < 65 kg

• A positive malaria smear (asexual P. falciparum parasitemia > 500/µL blood) without clinical symptoms (fever or self-reported fever in last 7 days, headache, malaise)

• If female, not pregnant (tested by pregnancy test) and not breastfeeding

• No mineral and vitamin supplements two weeks before and during the study

Exclusion Criteria:

• Severe anemia (hemoglobin < 8.0 g/dl)

• Chronic medical illnesses

• Blood donation or transfusion in the last 6 months before study time

• Soil-transmitted helminth infections (positive Kato-Katz-Smear)

• Tuberculosis (TB): The potential presence of TB will be excluded by a short health questionnaire (cough? night sweats? weight loss? close relative with TB?). If this questionnaire raises the possibility that the subject may be at risk for TB, he/she will be referred to the local medical service

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Antimalarial treatment

Other:
• Observation

Locations

Country	Name	City	State
Benin	Hopital de zone de Natitingou	Natitingou

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	European Union

Country where clinical trial is conducted

Benin,