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Study of Iron Absorption and Utilization in Asymptomatic Malaria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01108939
First Posted: April 22, 2010
Last Update Posted: June 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European Union
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
  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 Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (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 Prof. Michael B. Zimmermann, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 21, 2010
First Posted: April 22, 2010
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology:
Malaria, Iron absorption, Iron utilization, Benin

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