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Iron Absorption From GDS Capsules II

Primary Purpose

Iron Deficiency

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
GDS capsule with meal
Ferrous sulfate with meal
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Deficiency focused on measuring Iron absorption, Slow release iron, Gastric delivery system, Iron deficiency

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Human Nutrition Laboratory, ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GDS (gastric delivery system), meal

Ferrous sulfate, meal

Arm Description

GDS capsule with meal

Ferrous sulfate with meal

Outcomes

Primary Outcome Measures

Fractional iron absorption

Secondary Outcome Measures

Serum isotope appearance

Full Information

First Posted
October 31, 2013
Last Updated
July 29, 2014
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01985386
Brief Title
Iron Absorption From GDS Capsules II
Official Title
Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System (Ferrous Sulfate)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency
Keywords
Iron absorption, Slow release iron, Gastric delivery system, Iron deficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GDS (gastric delivery system), meal
Arm Type
Experimental
Arm Description
GDS capsule with meal
Arm Title
Ferrous sulfate, meal
Arm Type
Active Comparator
Arm Description
Ferrous sulfate with meal
Intervention Type
Dietary Supplement
Intervention Name(s)
GDS capsule with meal
Intervention Description
GDS capsule with meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferrous sulfate with meal
Intervention Description
Ferrous sulfate with meal
Primary Outcome Measure Information:
Title
Fractional iron absorption
Time Frame
2 weeks after test meal consumption
Secondary Outcome Measure Information:
Title
Serum isotope appearance
Time Frame
1, 2, 4 and 8 hours on days 1 and 8
Other Pre-specified Outcome Measures:
Title
Serum non transferrin bound iron
Time Frame
1, 2, 4 and 8 hours on days 1 and 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Aeberli, PhD
Organizational Affiliation
ETH Zurich (Switzerland)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Laboratory, ETH Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

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Iron Absorption From GDS Capsules II

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