Duration of Vitamin D Stores After Prolonged Vitamin D Substitution
1 other identifier
observational
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 13, 2012
CompletedFirst Posted
Study publicly available on registry
November 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedSeptember 22, 2015
September 1, 2015
2.5 years
November 13, 2012
September 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
half-life of serum 25-hydroxyvitamin D
up to 12 months
Study Arms (2)
subjects previously given placebo
subjects previously given vitamin D
Eligibility Criteria
Subjects who have previously participated in a vitamin D study
You may qualify if:
- previously participated in a vitamin D study
You may not qualify if:
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tromsø
Tromsø, Tromsø, 9037, Norway
Related Publications (1)
Martinaityte I, Kamycheva E, Didriksen A, Jakobsen J, Jorde R. Vitamin D Stored in Fat Tissue During a 5-Year Intervention Affects Serum 25-Hydroxyvitamin D Levels the Following Year. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3731-3738. doi: 10.1210/jc.2017-01187.
PMID: 28973683DERIVED
Biospecimen
blood samples and fat biopsy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
rolf jorde, professor
University of Tromso
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2012
First Posted
November 20, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2015
Study Completion
August 1, 2015
Last Updated
September 22, 2015
Record last verified: 2015-09