Study of Iron Absorption and Utilization in Asymptomatic Malaria
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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 |
| 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 |
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| Benin | |
| Hopital de zone de Natitingou | |
| Natitingou, Benin, 07 | |
| 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 Protozoan Infections Parasitic Diseases Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013