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CompletedNCT01108939Updated Jun 7, 2013

Study of Iron Absorption and Utilization in Asymptomatic Malaria

An Early Phase 1 interventional study of Antimalarial treatment and Observation in Malaria, Falciparum, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Benin. Open to female participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2013-06-07.

Sponsored by Swiss Federal Institute of Technology · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
23
Ages
16 Years to 35 Years
Sex
Female
01

Study summary

Anemia is still a main public health problem in sub-Saharan Africa. Anemic women have an increased maternal and perinatal mortality and anemic adults have diminished work capacity. In sub-Saharan Africa, the etiology of anemia is multifactoral; the major causes are low dietary bioavailability and chronic parasitic infections such as malaria. These causes are likely to interact because infection and infection-associated inflammation may impair the utilization and absorption of iron. Therefore, the control of parasite infections may be important to improve iron bioavailability from foods.

Malaria infections are endemic in northern Benin. To investigate the contribution of asymptomatic malaria (a positive blood smear for malarial parasites but without clinical symptoms of fever, headache or malaise) to anemia, we are planning a human iron absorption study in Benin. We will recruit adults with asymptomatic malaria infection. The iron absorption and utilization of the study subjects will be studied while infected, then they will be treated to clear their infections, and then iron absorption and utilization will be restudied. Iron absorption will be determined by incorporation of labeled iron into erythrocytes, 14 days after the administration of a test meal containing labeled iron (stable isotope technique). Subjects will be men and non-pregnant, non-breastfeeding women with a body weight \< 65 kg and between the age of 18 - 30 years.

The results of this study will provide important information on the influence of malaria infections on iron absorption and utilization in humans. The study will provide insight into the potential necessity of malaria control to ensure iron bioavailability from foods in developing countries.

02

Conditions studied

  • Malaria, Falciparum

Keywords

  • Malaria, Iron absorption, Iron utilization, Benin
03

In context

Malaria, Falciparum

455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.

This study's enrollment of 23 is below the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.

Browse Malaria, Falciparum studies →

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-35 y
  • Body weight \< 65 kg
  • A positive malaria smear (asexual P. falciparum parasitemia > 500/μL blood) without clinical symptoms (fever or self-reported fever in last 7 days, headache, malaise)
  • If female, not pregnant (tested by pregnancy test) and not breastfeeding
  • No mineral and vitamin supplements two weeks before and during the study

Exclusion criteria

Exclusion Criteria:

  • Severe anemia ( \< 8.0 g/dl)
  • Chronic medical illnesses
  • Blood donation or transfusion in the last 6 months before study time
  • Soil-transmitted helminth infections (positive Kato-Katz-Smear)
  • Tuberculosis (TB): The potential presence of TB will be excluded by a short health questionnaire (cough? night sweats? weight loss? close relative with TB?). If this questionnaire raises the possibility that the subject may be at risk for TB, he/she will be referred to the local medical service
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Antimalarial treatment

    Drug: Antimalarial treatment

  • Sham comparator
    Observation

    Other: Observation

Interventions

  • DrugAntimalarial treatment
  • OtherObservation
06

Study locations

1 site
  • Hopital de zone de Natitingou
    Natitingou, 07, Benin
07

References and documents

Publications

  • Cercamondi CI, Egli IM, Ahouandjinou E, Dossa R, Zeder C, Salami L, Tjalsma H, Wiegerinck E, Tanno T, Hurrell RF, Hounhouigan J, Zimmermann MB. Afebrile Plasmodium falciparum parasitemia decreases absorption of fortification iron but does not affect systemic iron utilization: a double stable-isotope study in young Beninese women. Am J Clin Nutr. 2010 Dec;92(6):1385-92. doi: 10.3945/ajcn.2010.30051. Epub 2010 Oct 6. Erratum In: Am J Clin Nutr. 2015 Apr;101(4):894. doi: 10.3945/ajcn.115.107805. PubMed 20926522 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01108939
Collaborators
European Union
Responsible party
Prof. Michael B. Zimmermann (Prof., Swiss Federal Institute of Technology) — Principal investigator
First posted
Apr 22, 2010
Start date
Feb 2009
Primary completion
Sep 2009
Completion
Apr 2010
Last update
Jun 7, 2013

Study contacts

Michael Zimmermann, Prof., MD
principal investigator · Human Nutrition Laboratory, Swiss Federal Institute of Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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