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Vitamin D DeficiencyPhase 3D-CORNCT02750293

The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors

A Phase 3 study testing Cholecalciferol in people with Vitamin D Deficiency, run by University of Tromso at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint Read more about this study

Who is it for?
Ages 20 to 80 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
411 participants
Where
1 siteNorway
Study dates
Jun 2015to Sep 2017
Phase
Phase 3
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • participated in The 7th survey in The Tromsø study
  • vitamin D deficiency

Who cannot join

  • primary hyperparathyroidism
  • granulomatous disease
  • reduced kidney function
  • systolic blood pressure > 174 mmHg
  • diastolic blood pressure > 104 mmHg
  • diabetes
Show all 13Show fewer
  • renal stones last 5 years
  • use of solarium on regular basis
  • planned holidays in tropical areas
  • clinical depression
  • clinical signs of vitamin D deficiency (muscle weakness)
  • use of vitamin D supplements
  • serious illness

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • University Hospital of North Norway

    Tromsø, 9038

Other trials in Norway

About this study

Official title: The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors in Subjects With Low Serum 25-hydroxyvitamin D Levels

Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint

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 cardio-vascular disease (CVD) and type 2 diabetes, and also with risk factors for these diseases like hypertension, dyslipidemia, insulin resistance, and endothelial dysfunction. However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors. Most of these studies were done in white, Western populations in subjects fairly vitamin D sufficient, and accordingly, no benefits were to be expected. Also, in many studies the doses of vitamin D have been too low, and the studies underpowered. To firmly establish the role of vitamin D regarding CVD risk factors we will in the present study include 600 subjects with vitamin D deficiency (serum 25-hydroxyvitamin D (25(OH)D) < 30 nmol/L) and randomize to high dose vitamin D (3000 IU per day) versus placebo for four months. The subjects will be recruited based on 25(OH)D measurements in the forthcoming 7th survey in the Tromsø study where more than 20 000 subjects are expected to attend. If our hypotheses are correct and the vitamin D supplement has a positive effect, this will be of great importance not only in countries with low sun exposure, but particularly for subjects in developing countries where vitamin D deficiency is highly prevalent.

Being tested
Cholecalciferol, Placebo
Keywords
vitamin D, blood pressure, serum lipids, glucose metabolism, muscle function, arterial stiffness, depression, psoriasis, sleep, bone density
Medical subject headings
Vitamin D Deficiency, Depression, Psoriasis

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 groups in NCT02750293
Study groupRoleWhat they receive
cholecalciferolActive comparatorvitamin D (as a 20 000 IU capsule) will be given once a week for 4 months
Receives: Drug: Cholecalciferol
placeboPlacebo comparatorplacebo capsules (identical looking to the vitamin D capsules) will be given once a week for 4 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in systolic and diastolic blood pressure

    Measured: 4 months

Secondary outcomes (32)

  1. Change from baseline in hand-grip, quadriceps and biceps muscle strength measured by hand held dynamometry .

    Measured: 4 months

  2. Change from baseline in score on Becks Depression Inventory

    Measured: 4 months

  3. Change from baseline in cognitive function evaluated with The Twelve Word Memory Test

    Measured: 4 months

  4. Change from baseline in cognitive function evaluated with The Digit Symbol Coding Test

    Measured: 4 months

  5. Change from baseline in cognitive function evaluated with The Tapping Test

    Measured: 4 months

  6. Change from baseline in arterial stiffness and endothelial function evaluated with pulse wave velocity

    Measured: 4 months

  7. Change from baseline in arterial stiffness and endothelial function evaluated with augmentation index (AIX)

    Measured: 4 months

  8. Change from baseline in arterial stiffness and endothelial function evaluated with the subendocardial viability ratio (SEVR)

    Measured: 4 months

  9. Change from baseline in number of subjects with nasal staphylococcus aureus colonization

    Measured: 4 months

  10. Change from baseline in bone mass density measured with dual energy x-ray absorptiometry (DEXA) at the lumbar spine and hip

    Measured: 4 months

  11. Change from baseline in the bone turnover marker serum type 1 procollagen (P1NP)

    Measured: 4 months

  12. Change from baseline in the bone turnover marker serum collagen type 1 cross-linked C-telopeptide (CTX-1)

    Measured: 4 months

  13. Change from baseline in serum marker of interferon-γ mediated macrophage activation

    Measured: 4 months

  14. Change from baseline in serum vitamin B6 status.

    Measured: 4 months

  15. Change from baseline in the glycosylation marker HbA1c

    Measured: 4 months

  16. Change from baseline in the glycosylation marker the receptor for advanced glycosylation end products (s-RAGE)

    Measured: 4 months

  17. Change from baseline in the glycosylation marker carboxy-methyllysine

    Measured: 4 months

  18. Change from baseline in psoriasis Activity in subjects with psoriasis evaluated with the Self-Administered Psoriasis Area Severity Index (SAPASI)

    Measured: 4 months

  19. Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Dermatological Life Quality Index (DLQI)

    Measured: 4 months

  20. Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Psoriasis Area Severity Index (PASI)

    Measured: 4 months

  21. Change from baseline in transcriptomic profile (mRNA) in adipose tissue biopsies

    Measured: 4 months

  22. Change from baseline in number of subjects with nocturnal legg cramps

    Measured: 4 months

  23. Change from baseline in sleep pattern evaluated with the Tromsø Study 7th Survey sleep pattern questionnaire

    Measured: 4 months

  24. Change from baseline in the serum total cholesterol

    Measured: 4 months

  25. Change from baseline in the serum HDL-cholesterol

    Measured: 4 months

  26. Change from baseline in the serum LDL-cholesterol

    Measured: 4 months

  27. Change from baseline in the serum triglycerides

    Measured: 4 months

  28. Change from baseline in the serum Apolipoprotein A1

    Measured: 4 months

  29. Change from baseline in the serum Apolipoprotein B,

    Measured: 4 months

  30. Change from baseline in insulin resistance evaluated with the homeostasis model assessment (HOMA) index based on fasting serum glucose and serum insulin

    Measured: 4 months

  31. 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: 4 months

  32. 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: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionAug 2017
  4. Study completionSep 2017

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02750293
Sponsor's protocol ID
TromsøEndo-2013-1
Other IDs
2013-003514-40
Acronym
D-COR
Status last verified
Oct 2017
First submitted
12 Apr 2016
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No: not planned

Publications

  • Jorde R, Kubiak J, Svartberg J, Fuskevag OM, Figenschau Y, Martinaityte I, Grimnes G. Vitamin D supplementation has no effect on cognitive performance after four months in mid-aged and older subjects. J Neurol Sci. 2019 Jan 15;396:165-171. doi: 10.1016/j.jns.2018.11.020. Epub 2018 Nov 17.

    PubMed 30472553

Questions about this trial

What is this clinical trial studying?

A Phase 3 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 13 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 26 Oct 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 systolic and diastolic blood pressure (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02750293, which also lists 1 linked publication.

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 26 Oct 2017.

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