Iron Absorption From GDS Capsules II

July 29, 2014 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System (Ferrous Sulfate)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Human Nutrition Laboratory, ETH Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GDS (gastric delivery system), meal
GDS capsule with meal
Dietary supplement: GDS capsule with meal
GDS capsule with meal
Active Comparator: Ferrous sulfate, meal
Ferrous sulfate with meal
Dietary supplement: Ferrous sulfate with meal
Ferrous sulfate with meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fractional iron absorption
Time Frame: 2 weeks after test meal consumption
2 weeks after test meal consumption

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum isotope appearance
Time Frame: 1, 2, 4 and 8 hours on days 1 and 8
1, 2, 4 and 8 hours on days 1 and 8

Other Outcome Measures

Outcome Measure
Time Frame
Serum non transferrin bound iron
Time Frame: 1, 2, 4 and 8 hours on days 1 and 8
1, 2, 4 and 8 hours on days 1 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 2013-N-05-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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