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

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

PHASE2

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Cholecalciferol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Rolf Jorde, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Tromsø, Tromsø, Norway

Locations

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Clinical Research Unit, University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED

PMID: 20056003 (View on PubMed)

Other Identifiers

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CSEMDT-2005-2

Identifier Type: -

Identifier Source: org_study_id