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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01163877
Other study ID # EK-2009-N-19
Secondary ID
Status Completed
Phase N/A
First received July 14, 2010
Last updated October 11, 2013
Start date April 2010
Est. completion date September 2013

Study information

Verified date October 2013
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority Switzerland: EthikkommissionCote d'Ivoire: National Research and Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 16 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

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.

Locations

Country Name City State
Côte D'Ivoire Taabo Cité Hospital Taabo

Sponsors (1)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Côte D'Ivoire, 

References & Publications (4)

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. — View Citation

Rohner F, Zimmermann MB, Amon RJ, Vounatsou P, Tschannen AB, N'goran EK, Nindjin C, Cacou MC, Té-Bonlé 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. — View 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.

Wegmüller 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Isotope absorption into blood stream Day 15 No
Primary Isotope absorption into blood stream Day 43 No
Secondary Isotope incorporation into erythrocytes Day 15 No
Secondary Biochemical parameters of iron status and infection Day 1 No
Secondary Biochemical parameters of iron status and infection Day 15 No
Secondary Biochemical parameters of iron status and infection Day 29 No
Secondary Biochemical parameters of iron status and infection Day 43 No
Secondary Isotope incorporation into erythrocytes Day 43 No
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