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

NCT ID: NCT01163877

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Malaria, Falciparum Hookworm Infections Schistosoma Haematobium

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Symptomatic malaria infection

Group Type OTHER

Fe-57 orally, Fe-58 intravenously

Intervention Type DIETARY_SUPPLEMENT

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

Group Type OTHER

Fe-57 orally, Fe-58 intravenously

Intervention Type DIETARY_SUPPLEMENT

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

Group Type OTHER

Fe-57 orally, Fe-58 intravenously

Intervention Type DIETARY_SUPPLEMENT

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

Group Type OTHER

Fe-57 orally, Fe-58 intravenously

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

\-
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rita Wegmüller, Dr.

Role: PRINCIPAL_INVESTIGATOR

Swiss Federal Institute of Technology (ETH) Zurich

Locations

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Taabo Cité Hospital

Taabo, , Côte d’Ivoire

Site Status

Countries

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Côte d’Ivoire

References

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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.

Reference Type BACKGROUND
PMID: 20107144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16772442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8172870 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 25733630 (View on PubMed)

Other Identifiers

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EK-2009-N-19

Identifier Type: -

Identifier Source: org_study_id