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Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma

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ClinicalTrials.gov Identifier: NCT01163877
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Malaria, Falciparum Hookworm Infections Schistosoma Haematobium Dietary Supplement: Fe-57 orally, Fe-58 intravenously

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma.
Study Start Date : April 2010
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Symptomatic malaria infection Dietary Supplement: Fe-57 orally, Fe-58 intravenously
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.
Asymptomatic malaria infection Dietary Supplement: Fe-57 orally, Fe-58 intravenously
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.
Hookworm infection Dietary Supplement: Fe-57 orally, Fe-58 intravenously
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.
Schistosoma haematobium infection Dietary Supplement: Fe-57 orally, Fe-58 intravenously
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.


Outcome Measures

Primary Outcome Measures :
  1. Isotope absorption into blood stream [ Time Frame: Day 15 ]
  2. Isotope absorption into blood stream [ Time Frame: Day 43 ]

Secondary Outcome Measures :
  1. Isotope incorporation into erythrocytes [ Time Frame: Day 15 ]
  2. Biochemical parameters of iron status and infection [ Time Frame: Day 1 ]
  3. Biochemical parameters of iron status and infection [ Time Frame: Day 15 ]
  4. Biochemical parameters of iron status and infection [ Time Frame: Day 29 ]
  5. Biochemical parameters of iron status and infection [ Time Frame: Day 43 ]
  6. Isotope incorporation into erythrocytes [ Time Frame: Day 43 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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): NCT01163877


Locations
Côte D'Ivoire
Taabo Cité Hospital
Taabo, Côte D'Ivoire
Sponsors and Collaborators
Swiss Federal Institute of Technology
Investigators
Principal Investigator: Rita Wegmüller, Dr. Swiss Federal Institute of Technology (ETH) Zurich
More Information

Publications:
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: NCT01163877     History of Changes
Other Study ID Numbers: EK-2009-N-19
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

Keywords provided by Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology:
iron absorption
iron utilization
malaria
helminth
Ivory Coast
Acute symptomatic uncomplicated falciparum malaria
Asymptomatic falciparum malaria
Moderate to heavy hookworm infection
Heavy Schistosoma haematobium infection

Additional relevant MeSH terms:
Hookworm Infections
Ancylostomiasis
Infection
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs