Malaria, FalciparumNCT01163877
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma
A study testing Fe-57 orally, Fe-58 intravenously in people with Malaria, Falciparum and Hookworm Infections, run by Swiss Federal Institute of Technology at 1 site in Côte d’Ivoire.
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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Malaria, Falciparum, Hookworm Infections, Schistosoma Haematobium
- What is being tested?
- Fe-57 orally, Fe-58 intravenously
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- Apr 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma.
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.
Read the 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.
- Being tested
- Fe-57 orally, Fe-58 intravenously
- 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
- Medical subject headings
- Malaria, Falciparum, Hookworm Infections, Schistosomiasis haematobia, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fe-57 orally, Fe-58 intravenouslyDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic malaria infection | Other | Not described Receives: Dietary Supplement: Fe-57 orally, Fe-58 intravenously |
| Asymptomatic malaria infection | Other | Not described Receives: Dietary Supplement: Fe-57 orally, Fe-58 intravenously |
| Hookworm infection | Other | Not described Receives: Dietary Supplement: Fe-57 orally, Fe-58 intravenously |
| Schistosoma haematobium infection | Other | Not described Receives: Dietary Supplement: Fe-57 orally, Fe-58 intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isotope absorption into blood stream
Measured: Day 15
Isotope absorption into blood stream
Measured: Day 43
Secondary outcomes (6)
Isotope incorporation into erythrocytes
Measured: Day 15
Biochemical parameters of iron status and infection
Measured: Day 1
Biochemical parameters of iron status and infection
Measured: Day 15
Biochemical parameters of iron status and infection
Measured: Day 29
Biochemical parameters of iron status and infection
Measured: Day 43
Isotope incorporation into erythrocytes
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Rita Wegmüller, Dr., Principal investigator, Swiss Federal Institute of Technology (ETH) Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163877
- Sponsor's protocol ID
- EK-2009-N-19
- Status last verified
- Oct 2013
- First submitted
- 14 Jul 2010
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20107144Wegmuller 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.
PubMed 16772442Kastenmayer 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.
PubMed 8172870Walczyk 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.
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.
PubMed 25733630
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma.
- ClinicalTrials.gov ID
- NCT01163877
- Acronym / sponsor ID
- EK-2009-N-19
- Keywords
- iron absorption, iron utilization, malaria, helminth, Ivory Coast, Acute symptomatic uncomplicated falciparum malaria, Asymptomatic falciparum malaria, Moderate to heavy hookworm infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fe-57 orally, Fe-58 intravenouslySubjects 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. | Dietary supplement | Asymptomatic malaria infection, Hookworm infection, Schistosoma haematobium infection, Symptomatic malaria infection |
Primary outcome
Isotope absorption into blood stream
Time frame: Day 15
Isotope absorption into blood stream
Time frame: Day 43
6 secondary outcomes
Isotope incorporation into erythrocytes
Time frame: Day 15
Biochemical parameters of iron status and infection
Time frame: Day 1
Biochemical parameters of iron status and infection
Time frame: Day 15
Biochemical parameters of iron status and infection
Time frame: Day 29
Biochemical parameters of iron status and infection
Time frame: Day 43
Isotope incorporation into erythrocytes
Time frame: Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
- Background: PubMed 20107144Rohner 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.
- Background: PubMed 16772442Wegmuller 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.
- Background: PubMed 8172870Kastenmayer 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.
- BackgroundWalczyk 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.
- Derived from this study: PubMed 25733630Glinz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Wegmüller, Dr. principal investigator
Swiss Federal Institute of Technology (ETH) Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fe-57 orally, Fe-58 intravenously in people with Malaria, Falciparum and Hookworm Infections, run by Swiss Federal Institute of Technology at 1 site in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isotope absorption into blood stream (time frame: Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01163877, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.