Treatment of Obesity With Vitamin D (40.000 IE Per Week f... | NCT00243256

Studies
Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)

NCT00243256

Sponsor

University of Tromso

Status

Completed

Last Update Posted

May 14, 2008Estimated

Enrollment

450Estimated

Phase

Phase 2

Conditions

Obesity

Interventions

Cholecalciferol

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

May 2008

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 2005

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Oct 20, 2005

First Submission Date that Met QC Criteria

Oct 20, 2005

First Posted Date

Oct 21, 2005Estimated

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

May 8, 2008

Last Update Posted Date

May 14, 2008Estimated

Description Module

Brief Summary

The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.

Detailed Description

We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.

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

450Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body Weight
Body composition
Measures of calcium metabolism
Insulin sensitivity
Muscle strength
Depression score
Blood pressure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 30 - 40
serum calcium < 2.55 mmol/L

Exclusion Criteria:

serious diseases
reduced kidney function
renal stone disease
using psychopharmaca
using drugs for weight reduction

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 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, Tromsø, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Unit, University Hospital of North Norway		Tromsø		9038	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20056003	Derived	Jorde R, Sneve M, Torjesen PA, Figenschau Y, Hansen JB, Grimnes G. No significant effect on bone mineral density by high doses of vitamin D3 given to overweight subjects for one year. Nutr J. 2010 Jan 7;9:1. doi: 10.1186/1475-2891-9-1.

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

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