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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01163877
First received: July 14, 2010
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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 Intervention
Malaria, Falciparum
Hookworm Infections
Schistosoma Haematobium
Dietary Supplement: Fe-57 orally, Fe-58 intravenously

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma.

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Isotope absorption into blood stream [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Isotope absorption into blood stream [ Time Frame: Day 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Isotope incorporation into erythrocytes [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Biochemical parameters of iron status and infection [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Biochemical parameters of iron status and infection [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Biochemical parameters of iron status and infection [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Biochemical parameters of iron status and infection [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
  • Isotope incorporation into erythrocytes [ Time Frame: Day 43 ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: April 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
Study First Received: July 14, 2010
Last Updated: October 11, 2013
Health Authority: Switzerland: Ethikkommission
Cote d'Ivoire: National Research and Ethics Committee

Keywords provided by 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
Malaria
Malaria, Falciparum
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Protozoan Infections
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014