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OpenTrials
Completed

NCT Number: NCT02783924

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

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

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

university Hospital of North Norway

Tromsø, 9038, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Vitamin D preparation

Other names: Dekristol

Placebo

Drug

placebo

Primary outcomes

  1. Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies

    Time frame: 2 months

Secondary outcomes

  1. 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)

    Time frame: 2 months

  2. 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)

    Time frame: 2 months

  3. Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response

    Time frame: 2 months

  4. 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

    Time frame: 2 months

  5. 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

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 26, 2016
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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