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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243256
• Other study ID #: CSEMDT-2005-2
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2005
• Last updated: May 8, 2008
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Cholecalciferol

Locations

Country	Name	City	State
Norway	Clinical Research Unit, University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight
Primary	Body composition
Primary	Measures of calcium metabolism
Primary	Insulin sensitivity
Primary	Muscle strength
Primary	Depression score
Primary	Blood pressure