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

Malaria, Falciparum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163877
• Other study ID #: EK-2009-N-19
• 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

Related Conditions & MeSH terms

• Hookworm Infections
• Malaria
• Malaria, Falciparum
• Schistosoma Haematobium

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