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The Significance of Vitamin D Storage in Adipose Tissue

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ClinicalTrials.gov Identifier: NCT01728987
Recruitment Status : Withdrawn (study stopped due to Financial problems)
First Posted : November 20, 2012
Last Update Posted : November 15, 2016
Information provided by (Responsible Party):
University of Tromso

Brief Summary:
The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.

Condition or disease Intervention/treatment Phase
Obesity Drug: cholecalciferol Drug: placebo Phase 2

Detailed Description:
vitamin d versus placebo will be given for 12 months. Biopsies will be taken at baseline and every 6 month for 2 years. Blood samples will be collected every 6th month. the study will thus give information on storage during vitamin d supplementation as well as use of vitamin d fat stores after stopping vitamin D supplementation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Significance of Vitamin D Storage in Adipose Tissue
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: cholecalciferol
vitamin d (cholecalciferol) will be given as a capsule of 20.000 Iu twice a week
Drug: cholecalciferol
as in arm description
Other Name: Dekristol
Placebo Comparator: placebo
the placebo capsules are looking identical to the vitamin d capsules and contain medium chain triglycerides and arachis oil
Drug: placebo
capsule looking identical to the cholecalciferol capsule

Primary Outcome Measures :
  1. vitamin D in adipose tissue biopsies [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. rate of decline of 25ohd in serum [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • hypercalcemia
  • pregnancy
  • women without safe contraception

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): NCT01728987

University of Tromsø
Tromsø, Norway, 9037
Sponsors and Collaborators
University of Tromso
Principal Investigator: rolf jorde, professor University of Tromsø, Norway

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01728987     History of Changes
Other Study ID Numbers: TromsøEndo-2012-1
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents