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

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

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

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

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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