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

Primary Purpose

Malaria, Falciparum, Hookworm Infections, Schistosoma Haematobium

Status
Completed
Phase
Not Applicable
Locations
Côte D'Ivoire
Study Type
Interventional
Intervention
Fe-57 orally, Fe-58 intravenously
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Malaria, Falciparum focused on measuring 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

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Taabo Cité Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Symptomatic malaria infection

Asymptomatic malaria infection

Hookworm infection

Schistosoma haematobium infection

Arm Description

Outcomes

Primary Outcome Measures

Isotope absorption into blood stream
Isotope absorption into blood stream

Secondary Outcome Measures

Isotope incorporation into erythrocytes
Biochemical parameters of iron status and infection
Biochemical parameters of iron status and infection
Biochemical parameters of iron status and infection
Biochemical parameters of iron status and infection
Isotope incorporation into erythrocytes

Full Information

First Posted
July 14, 2010
Last Updated
October 11, 2013
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01163877
Brief Title
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma
Official Title
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma.
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum, Hookworm Infections, Schistosoma Haematobium
Keywords
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic malaria infection
Arm Type
Other
Arm Title
Asymptomatic malaria infection
Arm Type
Other
Arm Title
Hookworm infection
Arm Type
Other
Arm Title
Schistosoma haematobium infection
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
Fe-57 orally, Fe-58 intravenously
Intervention Description
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.
Primary Outcome Measure Information:
Title
Isotope absorption into blood stream
Time Frame
Day 15
Title
Isotope absorption into blood stream
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
Isotope incorporation into erythrocytes
Time Frame
Day 15
Title
Biochemical parameters of iron status and infection
Time Frame
Day 1
Title
Biochemical parameters of iron status and infection
Time Frame
Day 15
Title
Biochemical parameters of iron status and infection
Time Frame
Day 29
Title
Biochemical parameters of iron status and infection
Time Frame
Day 43
Title
Isotope incorporation into erythrocytes
Time Frame
Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Wegmüller, Dr.
Organizational Affiliation
Swiss Federal Institute of Technology (ETH) Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taabo Cité Hospital
City
Taabo
Country
Côte D'Ivoire

12. IPD Sharing Statement

Citations:
PubMed Identifier
20107144
Citation
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.
Results Reference
background
PubMed Identifier
16772442
Citation
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.
Results Reference
background
PubMed Identifier
8172870
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
25733630
Citation
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.
Results Reference
derived

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

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