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Study of Iron Absorption and Utilization in Asymptomatic Malaria

Primary Purpose

Malaria, Falciparum

Status
Completed
Phase
Early Phase 1
Locations
Benin
Study Type
Interventional
Intervention
Antimalarial treatment
Observation
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria, Falciparum focused on measuring Malaria, Iron absorption, Iron utilization, Benin

Eligibility Criteria

16 Years - 35 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital de zone de Natitingou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Antimalarial treatment

Observation

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 21, 2010
Last Updated
June 6, 2013
Sponsor
Swiss Federal Institute of Technology
Collaborators
European Union
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1. Study Identification

Unique Protocol Identification Number
NCT01108939
Brief Title
Study of Iron Absorption and Utilization in Asymptomatic Malaria
Official Title
The Effect of Asymptomatic Malaria on Iron Absorption and Utilization From a Sorghum-based Meal in Adult Women in Benin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
European Union

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum
Keywords
Malaria, Iron absorption, Iron utilization, Benin

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antimalarial treatment
Arm Type
Experimental
Arm Title
Observation
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Antimalarial treatment
Intervention Type
Other
Intervention Name(s)
Observation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zimmermann, Prof., MD
Organizational Affiliation
Human Nutrition Laboratory, Swiss Federal Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital de zone de Natitingou
City
Natitingou
ZIP/Postal Code
07
Country
Benin

12. IPD Sharing Statement

Citations:
PubMed Identifier
20926522
Citation
Cercamondi CI, Egli IM, Ahouandjinou E, Dossa R, Zeder C, Salami L, Tjalsma H, Wiegerinck E, Tanno T, Hurrell RF, Hounhouigan J, Zimmermann MB. Afebrile Plasmodium falciparum parasitemia decreases absorption of fortification iron but does not affect systemic iron utilization: a double stable-isotope study in young Beninese women. Am J Clin Nutr. 2010 Dec;92(6):1385-92. doi: 10.3945/ajcn.2010.30051. Epub 2010 Oct 6. Erratum In: Am J Clin Nutr. 2015 Apr;101(4):894.
Results Reference
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Study of Iron Absorption and Utilization in Asymptomatic Malaria

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