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CompletedNCT01985386Updated Jul 30, 2014

Iron Absorption From GDS Capsules II

An interventional study of GDS capsule with meal and Ferrous sulfate with meal in Iron Deficiency, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-30.

Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

Slow release iron capsules containing ferrous sulfate have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.

02

Conditions studied

  • Iron Deficiency

Keywords

  • Iron absorption
  • Slow release iron
  • Gastric delivery system
  • Iron deficiency
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 8 is below the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 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
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • female,
  • age 18-50 years,
  • max. body weight 65 kg,
  • serum ferritin \< 30 µg/l

Exclusion criteria

Exclusion Criteria:

  • pregnancy,
  • lactation,
  • regular intake of medication,
  • blood donation or significant blood losses over the past 4 months
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    GDS (gastric delivery system), meal

    GDS capsule with meal

    Dietary Supplement: GDS capsule with meal

  • Active comparator
    Ferrous sulfate, meal

    Ferrous sulfate with meal

    Dietary Supplement: Ferrous sulfate with meal

Interventions

  • Dietary supplementGDS capsule with meal

    GDS capsule with meal

  • Dietary supplementFerrous sulfate with meal

    Ferrous sulfate with meal

06

What researchers measure

Primary outcomes

  1. Fractional iron absorption

    Time frame: 2 weeks after test meal consumption

Secondary outcomes

  1. Serum isotope appearance

    Time frame: 1, 2, 4 and 8 hours on days 1 and 8

Other outcomes

  1. Serum non transferrin bound iron

    Time frame: 1, 2, 4 and 8 hours on days 1 and 8

07

Study locations

1 site
  • Human Nutrition Laboratory, ETH Zurich
    Zurich, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01985386
Lead sponsor
Swiss Federal Institute of Technology
Responsible party
Prof. Michael B. Zimmermann (Prof., Swiss Federal Institute of Technology) — Principal investigator
First posted
Nov 15, 2013
Start date
Nov 2013
Primary completion
Dec 2013
Completion
Jun 2014
Last update
Jul 30, 2014

Study contacts

Isabelle Aeberli, PhD
principal investigator · ETH Zurich (Switzerland)

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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