Not Signed In -
Obesity |
Overweight |
Clinical Trial: Treatment of Obesity With Vitamin D
This study is not yet open for patient recruitment.
Verified by University of Tromso September 2005
|
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 II |
MedlinePlus related topics: Obesity
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Further study details as provided by University of Tromso:
Primary Outcomes: Body Weight; Body composition; Measures of calcium metabolism; Insulin sensitivity; Muscle strength; Depression score; Blood pressure
Expected Total Enrollment: 450
Expected Total Enrollment: 450
Study start: November 2005; Expected completion: December 2007
Last follow-up: July 2007; Data entry closure: November 2007
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 - 70 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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
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Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00243256
Rolf Jorde, Professor + 47 776 26827 rolf.jorde@unn.no
Norway
Clinical Research Unit, University Hospital of North Norway, Tromsø, 9038, Norway
Study chairs or principal investigators
Rolf Jorde, Professor, Principal Investigator, University of Tromsø, Tromsø, Norway
More Information
Study ID Numbers: CSEMDT-2005-2
Last Updated: December 8, 2005
Record first received: October 20, 2005
ClinicalTrials.gov Identifier: NCT00243256
Health Authority: Norway: Norwegian Medicines Agency
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: October 20, 2005
ClinicalTrials.gov Identifier: NCT00243256
Health Authority: Norway: Norwegian Medicines Agency
ClinicalTrials.gov processed this record on 2006-01-10
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