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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783924
• Other study ID #: TromsøEndo-2012-2
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: May 2018

Study information

• Verified date: November 2016
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in adipose tissue will be studied in 50 subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
Vitamin D preparation
• Placebo
placebo

Locations

Country	Name	City	State
Norway	university Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies		2 months
Secondary	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
Secondary	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
Secondary	Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response		2 months
Secondary	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
Secondary	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