NCT01728987

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2016

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
3.7 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

September 3, 2012

Last Update Submit

November 14, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • vitamin D in adipose tissue biopsies

    12 months

Secondary Outcomes (1)

  • rate of decline of 25ohd in serum

    12 months

Study Arms (2)

cholecalciferol

ACTIVE COMPARATOR

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

Drug: cholecalciferol

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

cholecalciferolDRUG

as in arm description

Also known as: Dekristol
cholecalciferol
placeboDRUG

capsule looking identical to the cholecalciferol capsule

placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects

You may not qualify if:

  • hypercalcemia
  • pregnancy
  • women without safe contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tromsø

Tromsø, Tromsø, 9037, Norway

Location

MeSH Terms

Conditions

Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • rolf jorde, professor

    University of Tromsø, Norway

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2012

First Posted

November 20, 2012

Study Start

August 1, 2016

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

NO(1)