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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02979132
Other study ID # Fe_LTL_Swi
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date March 31, 2019

Study information

Verified date October 2018
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections and are therefore of limited use in populations carrying a high burden of infection and inflammation, as for example women of reproductive age in malaria endemic areas in developing countries. Even without the confounding effect of inflammation, current markers of iron status are insensitive to small changes in dietary iron and do not allow to establish associations between dietary, lifestyle and genetic factors and iron balance. With a new method based on the dilution of a previously administered and equilibrated stable isotope signal, an accurate measurement of long-term oral iron balance and absorption is possible, allowing the estimation of iron requirements and potentially providing fundamental guidance for supplementation and fortification programs in both healthy and chronically inflamed/infected patients. In the current study the novel methodology will be validated in generally healthy subjects with low iron status. The technique will be used to assess dietary and lifestyle determinants of iron status and to compare the effect on iron balance and iron status of three distinct, commonly used iron interventions: food fortification with iron; oral iron supplementation, and intravenous iron infusion.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date March 31, 2019
Est. primary completion date July 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Have participated in a former absorption study in our lab,

- Signed written informed consent to participate in the new study,

- Serum ferritin < 25 µg/L

Exclusion Criteria:

- Anaemia (Hb < 117 g/L),

- Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),

- Allergic or similar reactions against iron supplements,

- Known fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency,

- Known hypersensitivity to ponceau R4 and ponceau R4 aluminium salt (E124)

- Continuous/long-term use of medication during the whole study (except for contraceptives),

- Regular consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration (more than 3 consecutive days or more than 5 times within 14 days),

- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,

- pregnancy or breast feeding,

- Intention to become pregnant during the course of the study,

- Known or suspected non-compliance, drug or alcohol abuse,

- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

- Participation in another study with investigational drug within the 30 days preceding and during the present study,

- Enrollment of the investigator, his/her family members, employees and other dependent persons

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Eisensulfat LOMAPHARM 50 mg
oral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days
Ferinject(R)
Single-dose Ferinject(R) administration
Dietary Supplement:
iron fortified biscuits
consumption of an iron-fortfied biscuit every morning for 90 days

Locations

Country Name City State
Switzerland Human Nutrition Laboratory, ETH Zürich Zürich Zurich

Sponsors (1)

Lead Sponsor Collaborator
Prof. Michael B. Zimmermann

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary iron isotope composition in blood tracer to tracee rate in venous blood samples at different time points 9 months
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