Clinical trial NCT02783924: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitamin D Deficiency
Keywords: vitamin D
genomics
proteomics
metabolomics
adipose tissue
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies
timeFrame: 2 months
Secondary outcomes:
measure: 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)
timeFrame: 2 months
measure: 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)
timeFrame: 2 months
measure: Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response
timeFrame: 2 months
measure: 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
timeFrame: 2 months
measure: 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
timeFrame: 2 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: university Hospital of North Norway
Study officials:
affiliation: University of Tromso
name: rolf Jorde, Professor
role: PRINCIPAL_INVESTIGATOR
References: