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

Phase 2

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol; Drug: Placebo

• Registration Number: NCT02783924
• Lead Sponsor: University of Tromso

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Status Verified: 2016-11
• Primary Completion: 2017-09
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol	Cholecalciferol	Vitamin d (as a 20.000 IU capsule) will be given i a dose of 40.000 IU per week for two months
Placebo	Placebo	two capsules (identical looking to the vitamin D capsules) will be given per week for two months

Primary Outcome Measures

Name	Time	Method
Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies	2 months

Secondary Outcome Measures

Name	Time	Method
Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response	2 months
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
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
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 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

Trial Locations

Locations (1)

university Hospital of North Norway; 🇳🇴 Tromsø, Norway