The Significance of Vitamin D Storage in Adipose Tissue | NCT01728987

Studies
The Significance of Vitamin D Storage in Adipose Tissue

NCT01728987

Sponsor

University of Tromso

Status

Withdrawn

Last Update Posted

Nov 15, 2016Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Obesity

Interventions

cholecalciferol
placebo

Countries

Norway

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study stopped due to Financial problems

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Feb 2019Estimated

First Submitted Date

Sep 3, 2012

First Submission Date that Met QC Criteria

Nov 13, 2012

First Posted Date

Nov 20, 2012Estimated

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

Nov 14, 2016

Last Update Posted Date

Nov 15, 2016Estimated

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

The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.

Detailed Description

vitamin d versus placebo will be given for 12 months. Biopsies will be taken at baseline and every 6 month for 2 years. Blood samples will be collected every 6th month. the study will thus give information on storage during vitamin d supplementation as well as use of vitamin d fat stores after stopping vitamin D supplementation

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cholecalciferol	Active Comparator	vitamin d (cholecalciferol) will be given as a capsule of 20.000 Iu twice a week	Drug: cholecalciferol
placebo	Placebo Comparator	the placebo capsules are looking identical to the vitamin d capsules and contain medium chain triglycerides and arachis oil	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cholecalciferol	Drug	as in arm description	cholecalciferol	Dekristol

Measure	Description	Time Frame
vitamin D in adipose tissue biopsies		12 months

Measure	Description	Time Frame
rate of decline of 25ohd in serum		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects

Exclusion Criteria:

hypercalcemia
pregnancy
women without safe contraception

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
rolf jorde, professor	University of Tromsø, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tromsø		Tromsø	Tromsø	9037	Norway

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided