NCT01729013

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

2.5 years

First QC Date

November 13, 2012

Last Update Submit

September 18, 2015

Conditions

Keywords

vitamin Dfatbiopsy

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

Age25 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples and fat biopsy

MeSH Terms

Conditions

ObesityPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • rolf jorde, professor

    University of Tromso

    PRINCIPAL INVESTIGATOR

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

Locations