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Iron Absorption From GDS Capsules

NCT ID: NCT01874496

Last Updated: 2013-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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GDS, meal

GDS, meal

Group Type EXPERIMENTAL

GDS, meal

Intervention Type DIETARY_SUPPLEMENT

GDS, meal

GDS, no meal

GDS, no meal

Group Type EXPERIMENTAL

GDS, no meal

Intervention Type DIETARY_SUPPLEMENT

GDS, no meal

control, no meal

control, no meal

Group Type ACTIVE_COMPARATOR

control, no meal

Intervention Type DIETARY_SUPPLEMENT

control, no meal

control, meal

control, meal

Group Type ACTIVE_COMPARATOR

control, meal

Intervention Type DIETARY_SUPPLEMENT

control, meal

Interventions

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GDS, no meal

GDS, no meal

Intervention Type DIETARY_SUPPLEMENT

GDS, meal

GDS, meal

Intervention Type DIETARY_SUPPLEMENT

control, no meal

control, no meal

Intervention Type DIETARY_SUPPLEMENT

control, meal

control, meal

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Human Nutrition Laboratory, ETH Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK 2013-N-05

Identifier Type: -

Identifier Source: org_study_id