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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243256
First Posted: October 21, 2005
Last Update Posted: May 14, 2008
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.
Information provided by:
University of Tromso
  Purpose
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 Intervention Phase
Obesity Drug: Cholecalciferol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • Body Weight
  • Body composition
  • Measures of calcium metabolism
  • Insulin sensitivity
  • Muscle strength
  • Depression score
  • Blood pressure

Estimated Enrollment: 450
Study Start Date: November 2005
Study Completion Date: December 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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
Norway
Clinical Research Unit, University Hospital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University of Tromso
Investigators
Principal Investigator: Rolf Jorde, Professor University of Tromsø, Tromsø, Norway
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00243256     History of Changes
Other Study ID Numbers: CSEMDT-2005-2
First Submitted: October 20, 2005
First Posted: October 21, 2005
Last Update Posted: May 14, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents