Duration of Vitamin D Stores After Prolonged Vitamin D Substitution

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. Identifier: NCT01729013
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : September 22, 2015
Information provided by (Responsible Party):
University of Tromso

Brief Summary:
Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues. The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such storage which may potentially be of vital importance when intake or solar exposure is limited. In the present study we will include 76 subjects who have participated in an intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of type 2 diabetes, and who have completed the study after 5 years or who have been excluded because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D during the following year without vitamin D substitution, which will be measured in the present study. If our hypothesis is correct, that vitamin D can be stored in significant amounts when the supply is abundant; current advice on vitamin D supplementation mainly during winter should be changed to "year around" in order to build up sufficient stores for the months without sufficient sun light.

Condition or disease

Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duration of Vitamin D Stores After Prolonged Vitamin D Substitution
Study Start Date : November 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

subjects previously given placebo
subjects previously given vitamin D

Primary Outcome Measures :
  1. half-life of serum 25-hydroxyvitamin D [ Time Frame: up to 12 months ]

Biospecimen Retention:   Samples Without DNA
blood samples and fat biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have previously participated in a vitamin D study

Inclusion Criteria:

  • previously participated in a vitamin D study

Exclusion Criteria:

  • pregnancy

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 identifier (NCT number): NCT01729013

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Tromso Identifier: NCT01729013     History of Changes
Other Study ID Numbers: Tromsø-Endo-2012-2
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by University of Tromso:
vitamin D

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