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The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring vitamin D, genomics, proteomics, metabolomics, adipose tissue

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • serum 25OHD in the range 20 - 40 nmol/L
  • no change in medication last 4 weeks

Exclusion Criteria:

  • women < 60 yrs of age (to avoid influence of menstrual cycle)
  • reduced kidney function
  • serious diseases (cardio-vascular, diabetes, etc)
  • taking vitamin d supplementation

Sites / Locations

  • university Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol

Placebo

Arm Description

Vitamin d (as a 20.000 IU capsule) will be given i a dose of 40.000 IU per week for two months

two capsules (identical looking to the vitamin D capsules) will be given per week for two months

Outcomes

Primary Outcome Measures

Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies

Secondary Outcome Measures

Change from baseline in proteomic profile with relative quantification in adipose tissue biopsies with the use of Liquid chromatography mass spectrometry Technology (LC-MS/MS)
Change from baseline in metabolomic profile with relative quantification in adipose tissue biopsies with the use of Liquid chromatography mass spectrometry Technology (LC-MS/MS)
Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response
Effect of VDR (vitamin D receptor) polymorphisms on change from baseline in metabolomic profile with relative quantification in adipose tissue biopsies with the use of LC-MS/MS
Effect of VDR (vitamin D receptor) polymorphisms on change from baseline in proteomic profile with relative quantification in adipose tissue biopsies with the use of LC-MS/MS

Full Information

First Posted
April 22, 2016
Last Updated
May 23, 2018
Sponsor
University of Tromso
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1. Study Identification

Unique Protocol Identification Number
NCT02783924
Brief Title
The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach
Official Title
The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach to the Effects of Vitamin D in Adipose Tissue and Peripheral Blood
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in adipose tissue will be studied in 50 subjects.
Detailed Description
Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body. Lack of vitamin D is associated with coronary heart disease, cancer and immunological diseases, and also with obesity, hypertension and glucose intolerance. However, to see the full effect of vitamin D, one should not only look at single diseases or risk factors, but have a global approach using a combined clinical index. A similar line of thinking can be applied to genetic, proteomic and metabolomic studies on vitamin D. Thus, in the present study 50 subjects will be included and randomized to vitamin D 40.000 IU per week versus placebo for 2 months. Blood and adipose tissue samples will be collected before and after the intervention and analyzed for gene expression. Based on these results the investigators will proceed with the relevant proteomic and metabolomic profile analyses. If successful, this may reveal new aspects of vitamin D's physiology and metabolic effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D, genomics, proteomics, metabolomics, adipose tissue

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Description
Vitamin d (as a 20.000 IU capsule) will be given i a dose of 40.000 IU per week for two months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
two capsules (identical looking to the vitamin D capsules) will be given per week for two months
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Dekristol
Intervention Description
Vitamin D preparation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change from baseline in proteomic profile with relative quantification in adipose tissue biopsies with the use of Liquid chromatography mass spectrometry Technology (LC-MS/MS)
Time Frame
2 months
Title
Change from baseline in metabolomic profile with relative quantification in adipose tissue biopsies with the use of Liquid chromatography mass spectrometry Technology (LC-MS/MS)
Time Frame
2 months
Title
Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response
Time Frame
2 months
Title
Effect of VDR (vitamin D receptor) polymorphisms on change from baseline in metabolomic profile with relative quantification in adipose tissue biopsies with the use of LC-MS/MS
Time Frame
2 months
Title
Effect of VDR (vitamin D receptor) polymorphisms on change from baseline in proteomic profile with relative quantification in adipose tissue biopsies with the use of LC-MS/MS
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: serum 25OHD in the range 20 - 40 nmol/L no change in medication last 4 weeks Exclusion Criteria: women < 60 yrs of age (to avoid influence of menstrual cycle) reduced kidney function serious diseases (cardio-vascular, diabetes, etc) taking vitamin d supplementation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rolf Jorde, Professor
Organizational Affiliation
University of Tromso
Official's Role
Principal Investigator
Facility Information:
Facility Name
university Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
not planned

Learn more about this trial

The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach

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