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Iron Isotope Study of an Iron Fatty Acid Complex

NCT03895424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-08-28

No results posted yet for this study

Summary

The study aims at assessing the iron (Fe) bioavailability from a newly developed iron compound - an iron fatty acid complex. The iron from the compound is hypothesized to have a higher absorption rate than commonly available supplements in the market. The study is a cross over, human iron isotope study with three arms where participants consume the experimental dietary products in a randomized fashion. The study duration is of 45 days - from the day of the capsule administration till the last blood sampling point

Conditions

  • Iron-deficiency

Interventions

DIETARY_SUPPLEMENT

IFAC

This intervention will contain the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope 58Fe

DIETARY_SUPPLEMENT

MIFAC

This intervention will contain the micellarized form of the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope with 57Fe

DIETARY_SUPPLEMENT

Control Ferrous Sulfate

This intervention will contain ferrous sulfate in the form of a solution labelled with the iron isotope 54Fe. A capsule with the same amount of fat as in the other arms will be administered to the participants

Sponsors & Collaborators

  • Mibelle AG

    collaborator INDUSTRY

  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Michael Zimmermann, PhD · Swiss Federal Institute of Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2019-06-20
Completion
2019-06-20

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895424 on ClinicalTrials.gov