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

This study has been completed.
Sponsor:
Information provided by:
University of Tromso
ClinicalTrials.gov Identifier:
NCT00243256
First received: October 20, 2005
Last updated: May 8, 2008
Last verified: May 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Tromso

Additional 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
Study First Received: October 20, 2005
Last Updated: May 8, 2008
Health Authority: Norway: Norwegian Medicines Agency

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

ClinicalTrials.gov processed this record on October 22, 2014