Study of Iron Absorption and Utilization in Asymptomatic Malaria

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01108939
First received: April 21, 2010
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Malaria, Falciparum
Drug: Antimalarial treatment
Other: Observation
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Asymptomatic Malaria on Iron Absorption and Utilization From a Sorghum-based Meal in Adult Women in Benin

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Enrollment: 23
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antimalarial treatment Drug: Antimalarial treatment
Sham Comparator: Observation Other: Observation

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01108939

Locations
Benin
Hopital de zone de Natitingou
Natitingou, Benin, 07
Sponsors and Collaborators
Swiss Federal Institute of Technology
European Union
Investigators
Principal Investigator: Michael Zimmermann, Prof., MD Human Nutrition Laboratory, Swiss Federal Institute of Technology
  More Information

No publications provided by Swiss Federal Institute of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Michael B. Zimmermann, Prof., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01108939     History of Changes
Other Study ID Numbers: Fe_Malaria_Benin
Study First Received: April 21, 2010
Last Updated: June 6, 2013
Health Authority: Benin: Ministry of Health

Keywords provided by Swiss Federal Institute of Technology:
Malaria, Iron absorption, Iron utilization, Benin

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections
Antimalarials
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014