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The Significance of Vitamin D Storage in Adipose Tissue

NCT ID: NCT01728987

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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cholecalciferol

vitamin d (cholecalciferol) will be given as a capsule of 20.000 Iu twice a week

Group Type ACTIVE_COMPARATOR

cholecalciferol

Intervention Type DRUG

as in arm description

placebo

the placebo capsules are looking identical to the vitamin d capsules and contain medium chain triglycerides and arachis oil

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

capsule looking identical to the cholecalciferol capsule

Interventions

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cholecalciferol

as in arm description

Intervention Type DRUG

placebo

capsule looking identical to the cholecalciferol capsule

Intervention Type DRUG

Other Intervention Names

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Dekristol

Eligibility Criteria

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Inclusion Criteria

* healthy subjects

Exclusion Criteria

* hypercalcemia
* pregnancy
* women without safe contraception
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tromso

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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rolf jorde, professor

Role: PRINCIPAL_INVESTIGATOR

University of Tromsø, Norway

Locations

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University of Tromsø

Tromsø, Tromsø, Norway

Site Status

Countries

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Norway

Other Identifiers

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TromsøEndo-2012-1

Identifier Type: -

Identifier Source: org_study_id