- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163877
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma
October 11, 2013 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma.
The aim of this study is to investigate the change in iron metabolism in relation to malaria and helminth infections using a stable isotope technique.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The aim of the study is to determine how iron metabolism in subjects with infectious diseases (malaria, hookworm or S. haematobium) differs while infected and after treatment, i.e. the same individuals will be restudied while free of infection.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taabo, Côte D'Ivoire
- Taabo Cité Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children aged 12 to 16 years
- Body weight > 30 kg
- no chronic medical illnesses
- no intake of vitamin/mineral supplements 2 weeks before the study and until the last blood drawing
- For each of the 4 arms the respective disease needs to be present (symptomatic malaria, asymptomatic malaria, hookworm infection, S. haematobium infection) without any other concurrent infection
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Symptomatic malaria infection
|
Subjects will receive a test drink containing 3 mg Fe-57 in the form of labelled FeSO4 followed by 1 ml of an aqueous solution containing 50 μg Fe-58 as iron citrate.
|
|
OTHER: Asymptomatic malaria infection
|
Subjects will receive a test drink containing 3 mg Fe-57 in the form of labelled FeSO4 followed by 1 ml of an aqueous solution containing 50 μg Fe-58 as iron citrate.
|
|
OTHER: Hookworm infection
|
Subjects will receive a test drink containing 3 mg Fe-57 in the form of labelled FeSO4 followed by 1 ml of an aqueous solution containing 50 μg Fe-58 as iron citrate.
|
|
OTHER: Schistosoma haematobium infection
|
Subjects will receive a test drink containing 3 mg Fe-57 in the form of labelled FeSO4 followed by 1 ml of an aqueous solution containing 50 μg Fe-58 as iron citrate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Isotope absorption into blood stream
Time Frame: Day 15
|
Day 15
|
|
Isotope absorption into blood stream
Time Frame: Day 43
|
Day 43
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Isotope incorporation into erythrocytes
Time Frame: Day 15
|
Day 15
|
|
Biochemical parameters of iron status and infection
Time Frame: Day 1
|
Day 1
|
|
Biochemical parameters of iron status and infection
Time Frame: Day 15
|
Day 15
|
|
Biochemical parameters of iron status and infection
Time Frame: Day 29
|
Day 29
|
|
Biochemical parameters of iron status and infection
Time Frame: Day 43
|
Day 43
|
|
Isotope incorporation into erythrocytes
Time Frame: Day 43
|
Day 43
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rita Wegmüller, Dr., Swiss Federal Institute of Technology (ETH) Zurich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rohner F, Zimmermann MB, Amon RJ, Vounatsou P, Tschannen AB, N'goran EK, Nindjin C, Cacou MC, Te-Bonle MD, Aka H, Sess DE, Utzinger J, Hurrell RF. In a randomized controlled trial of iron fortification, anthelmintic treatment, and intermittent preventive treatment of malaria for anemia control in Ivorian children, only anthelmintic treatment shows modest benefit. J Nutr. 2010 Mar;140(3):635-41. doi: 10.3945/jn.109.114256. Epub 2010 Jan 27.
- Wegmuller R, Camara F, Zimmermann MB, Adou P, Hurrell RF. Salt dual-fortified with iodine and micronized ground ferric pyrophosphate affects iron status but not hemoglobin in children in Cote d'Ivoire. J Nutr. 2006 Jul;136(7):1814-20. doi: 10.1093/jn/136.7.1814.
- Kastenmayer P, Davidsson L, Galan P, Cherouvrier F, Hercberg S, Hurrell RF. A double stable isotope technique for measuring iron absorption in infants. Br J Nutr. 1994 Mar;71(3):411-24. doi: 10.1079/bjn19940148.
- Walczyk T, Davidsson L, Zavaleta N, Hurrell RF. Stable isotope labels as a tool to determine the iron absorption by Peruvian school children from a breakfast meal. Fresenius Journal of Analytical Chemistry 359: 445-449, 1997.
- Glinz D, Hurrell RF, Righetti AA, Zeder C, Adiossan LG, Tjalsma H, Utzinger J, Zimmermann MB, N'Goran EK, Wegmuller R. In Ivorian school-age children, infection with hookworm does not reduce dietary iron absorption or systemic iron utilization, whereas afebrile Plasmodium falciparum infection reduces iron absorption by half. Am J Clin Nutr. 2015 Mar;101(3):462-70. doi: 10.3945/ajcn.114.090175. Epub 2015 Feb 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (ACTUAL)
September 1, 2013
Study Completion (ACTUAL)
September 1, 2013
Study Registration Dates
First Submitted
July 14, 2010
First Submitted That Met QC Criteria
July 15, 2010
First Posted (ESTIMATE)
July 16, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
October 14, 2013
Last Update Submitted That Met QC Criteria
October 11, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK-2009-N-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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