The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach
1 other identifier
interventional
50
1 country
1
Brief Summary
The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in adipose tissue will be studied in 50 subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2014
Typical duration for phase_2
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
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 25, 2018
November 1, 2016
2.9 years
April 22, 2016
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies
2 months
Secondary Outcomes (5)
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)
2 months
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)
2 months
Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response
2 months
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
2 months
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
2 months
Study Arms (2)
Cholecalciferol
ACTIVE COMPARATORVitamin d (as a 20.000 IU capsule) will be given i a dose of 40.000 IU per week for two months
Placebo
PLACEBO COMPARATORtwo capsules (identical looking to the vitamin D capsules) will be given per week for two months
Interventions
Eligibility Criteria
You may qualify if:
- serum 25OHD in the range 20 - 40 nmol/L
- no change in medication last 4 weeks
You may not qualify if:
- women \< 60 yrs of age (to avoid influence of menstrual cycle)
- reduced kidney function
- serious diseases (cardio-vascular, diabetes, etc)
- taking vitamin d supplementation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
university Hospital of North Norway
Tromsø, 9038, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
rolf Jorde, Professor
University of Tromso
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
April 22, 2016
First Posted
May 26, 2016
Study Start
October 1, 2014
Primary Completion
September 1, 2017
Study Completion
May 1, 2018
Last Updated
May 25, 2018
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share
not planned