Iron Absorption From GDS Capsules II | NCT01985386

Studies
Iron Absorption From GDS Capsules II

NCT01985386

Sponsor

Swiss Federal Institute of Technology

Status

Completed

Last Update Posted

Jul 30, 2014Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Iron Deficiency

Interventions

GDS capsule with meal
Ferrous sulfate with meal

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Oct 31, 2013

First Submission Date that Met QC Criteria

Nov 8, 2013

First Posted Date

Nov 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2014

Last Update Posted Date

Jul 30, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Michael B. Zimmermann, Prof., Swiss Federal Institute of TechnologyPrincipal Investigator

Lead Sponsor

Swiss Federal Institute of TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GDS (gastric delivery system), meal	Experimental	GDS capsule with meal	Dietary Supplement: GDS capsule with meal
Ferrous sulfate, meal	Active Comparator	Ferrous sulfate with meal	Dietary Supplement: Ferrous sulfate with meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GDS capsule with meal	Dietary Supplement	GDS capsule with meal	GDS (gastric delivery system), meal

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle Aeberli, PhD	ETH Zurich (Switzerland)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Human Nutrition Laboratory, ETH Zurich		Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D000090463	Iron Deficiencies

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C020748	ferrous sulfate
D062407	Meals

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided