Iron Absorption From GDS Capsules

September 12, 2013 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

Slow release iron capsules 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)

4

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, 8092
        • 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 < 35µg/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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GDS, meal
Dietary supplement: GDS, meal
GDS, meal
EXPERIMENTAL: GDS, no meal
Dietary supplement: GDS, no meal
GDS, no meal
ACTIVE_COMPARATOR: control, no meal
Dietary supplement: control, no meal
control, no meal
ACTIVE_COMPARATOR: control, meal
Dietary supplement: control, meal
control, meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fractional iron absorption
Time Frame: 2, 4, 6, and 8 weeks
2, 4, 6, and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
serum isotope appearance
Time Frame: day 1, 15, 29 and 33
day 1, 15, 29 and 33

Other Outcome Measures

Outcome Measure
Time Frame
Serum non transferrin bound iron
Time Frame: day 1, 15, 29 and 33
day 1, 15, 29 and 33

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

May 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (ESTIMATE)

June 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 2013-N-05

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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