NCT01163877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

Enrollment Period

3.4 years

First QC Date

July 14, 2010

Last Update Submit

October 11, 2013

Conditions

Keywords

iron absorptioniron utilizationmalariahelminthIvory CoastAcute symptomatic uncomplicated falciparum malariaAsymptomatic falciparum malariaModerate to heavy hookworm infectionHeavy Schistosoma haematobium infection

Outcome Measures

Primary Outcomes (2)

  • Isotope absorption into blood stream

    Day 15

  • Isotope absorption into blood stream

    Day 43

Secondary Outcomes (6)

  • Isotope incorporation into erythrocytes

    Day 15

  • Biochemical parameters of iron status and infection

    Day 1

  • Biochemical parameters of iron status and infection

    Day 15

  • Biochemical parameters of iron status and infection

    Day 29

  • Biochemical parameters of iron status and infection

    Day 43

  • +1 more secondary outcomes

Study Arms (4)

Symptomatic malaria infection

OTHER
Dietary Supplement: Fe-57 orally, Fe-58 intravenously

Asymptomatic malaria infection

OTHER
Dietary Supplement: Fe-57 orally, Fe-58 intravenously

Hookworm infection

OTHER
Dietary Supplement: Fe-57 orally, Fe-58 intravenously

Schistosoma haematobium infection

OTHER
Dietary Supplement: Fe-57 orally, Fe-58 intravenously

Interventions

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 infectionHookworm infectionSchistosoma haematobium infectionSymptomatic malaria infection

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taabo Cité Hospital

Taabo, Côte d’Ivoire

Location

Related Publications (5)

  • 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.

    PMID: 20107144BACKGROUND
  • 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.

    PMID: 16772442BACKGROUND
  • 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.

    PMID: 8172870BACKGROUND
  • 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.

    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.

MeSH Terms

Conditions

Malaria, FalciparumHookworm InfectionsSchistosomiasis haematobiaMalaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesStrongylida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisSchistosomiasisTrematode InfectionsUrinary Tract InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Rita Wegmüller, Dr.

    Swiss Federal Institute of Technology (ETH) Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 16, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 14, 2013

Record last verified: 2013-10

Locations