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

University of Tromso (UiT)

Status and phase: Completed; Phase 2

Conditions: Vitamin D Deficiency

Treatments: Drug: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT02783924

TromsøEndo-2012-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Cholecalciferol

Active Comparator group

Description:

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

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo