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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00243256
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : May 14, 2008
Sponsor:
Information provided by:
University of Tromso

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Cholecalciferol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : November 2005
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D




Primary Outcome Measures :
  1. Body Weight
  2. Body composition
  3. Measures of calcium metabolism
  4. Insulin sensitivity
  5. Muscle strength
  6. Depression score
  7. Blood pressure


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243256


Locations
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Norway
Clinical Research Unit, University Hospital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University of Tromso
Investigators
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Principal Investigator: Rolf Jorde, Professor University of Tromsø, Tromsø, Norway
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00243256    
Other Study ID Numbers: CSEMDT-2005-2
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: May 2008
Additional relevant MeSH terms:
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Obesity
Cholecalciferol
Vitamin D
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents