Clinical trial NCT01163877: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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:

-

Primary outcomes:
measure: Isotope absorption into blood stream
timeFrame: Day 15
measure: Isotope absorption into blood stream
timeFrame: Day 43
Secondary outcomes:
measure: Isotope incorporation into erythrocytes
timeFrame: Day 15
measure: Biochemical parameters of iron status and infection
timeFrame: Day 1
measure: Biochemical parameters of iron status and infection
timeFrame: Day 15
measure: Biochemical parameters of iron status and infection
timeFrame: Day 29
measure: Biochemical parameters of iron status and infection
timeFrame: Day 43
measure: Isotope incorporation into erythrocytes
timeFrame: Day 43
Other outcomes:
Locations:
city: Taabo
country: Côte D'Ivoire
facility: Taabo Cité Hospital
Study officials:
affiliation: Swiss Federal Institute of Technology (ETH) Zurich
name: Rita Wegmüller, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.