Vitamin D DeficiencyPhase 2NCT02783924
The GLOBAL Vitamin D Study. A Genomic, Transcriptomic, Proteomic and Metabolomic Approach
A Phase 2 study testing Cholecalciferol in people with Vitamin D Deficiency, run by University of Tromso at 1 site in Norway.
Trial summary
The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in adipose tissue will be studied in 50 subjects. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- serum 25OHD in the range 20 - 40 nmol/L
- no change in medication last 4 weeks
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
The effect of vitamin D supplementation on genetic, proteomic , and metabolomic profile in adipose tissue will be studied in 50 subjects.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Cholecalciferol, Placebo
- Keywords
- vitamin D, genomics, proteomics, metabolomics, adipose tissue
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Dekristol
Vitamin D preparation
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Active comparator | Vitamin d (as a 20.000 IU capsule) will be given i a dose of 40.000 IU per week for two months Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | two capsules (identical looking to the vitamin D capsules) will be given per week for two months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies
Measured: 2 months
Secondary outcomes (5)
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)
Measured: 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)
Measured: 2 months
Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response
Measured: 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
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startOct 2014
- Primary completionSep 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- rolf Jorde, Professor, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783924
- Sponsor's protocol ID
- TromsøEndo-2012-2
- Status last verified
- Nov 2016
- First submitted
- 22 Apr 2016
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: not planned
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02783924
- Acronym / sponsor ID
- TromsøEndo-2012-2
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, genomics, proteomics, metabolomics, adipose tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Active comparator | Drug: CholecalciferolVitamin d (as a 20.000 IU capsule) will be given i a dose of 40.000 IU per week for two months |
| Placebo | Placebo comparator | Drug: Placebotwo capsules (identical looking to the vitamin D capsules) will be given per week for two months |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- serum 25OHD in the range 20 - 40 nmol/L
- no change in medication last 4 weeks
Key exclusion criteria (4 listed)
- women < 60 yrs of age (to avoid influence of menstrual cycle)
- reduced kidney function
- serious diseases (cardio-vascular, diabetes, etc)
- taking vitamin d supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: DekristolVitamin D preparation | Drug | Cholecalciferol |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies
Time frame: 2 months
5 secondary outcomes
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
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
Effect of DBP (vitamin D binding protein) polymorphisms on the serum 25OHD response
Time frame: 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
Time frame: 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
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: No. not planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rolf Jorde, Professor principal investigator
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with Vitamin D Deficiency, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mRNA (messenger ribonucleic acid) profile in adipose tissue biopsies (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.