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The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors (D-COR)

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ClinicalTrials.gov Identifier: NCT02750293
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Rolf Jorde, University of Tromso

Brief 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

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Cholecalciferol Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors in Subjects With Low Serum 25-hydroxyvitamin D Levels
Actual Study Start Date : June 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: cholecalciferol
vitamin D (as a 20 000 IU capsule) will be given once a week for 4 months
Drug: Cholecalciferol
Vitamin D preparation
Other Name: Dekristol

Placebo Comparator: placebo
placebo capsules (identical looking to the vitamin D capsules) will be given once a week for 4 months
Drug: Placebo
placebo




Primary Outcome Measures :
  1. Change from baseline in systolic and diastolic blood pressure [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Change from baseline in hand-grip, quadriceps and biceps muscle strength measured by hand held dynamometry . [ Time Frame: 4 months ]
  2. Change from baseline in score on Becks Depression Inventory [ Time Frame: 4 months ]
  3. Change from baseline in cognitive function evaluated with The Twelve Word Memory Test [ Time Frame: 4 months ]
  4. Change from baseline in cognitive function evaluated with The Digit Symbol Coding Test [ Time Frame: 4 months ]
  5. Change from baseline in cognitive function evaluated with The Tapping Test [ Time Frame: 4 months ]
  6. Change from baseline in arterial stiffness and endothelial function evaluated with pulse wave velocity [ Time Frame: 4 months ]
  7. Change from baseline in arterial stiffness and endothelial function evaluated with augmentation index (AIX) [ Time Frame: 4 months ]
  8. Change from baseline in arterial stiffness and endothelial function evaluated with the subendocardial viability ratio (SEVR) [ Time Frame: 4 months ]
  9. Change from baseline in number of subjects with nasal staphylococcus aureus colonization [ Time Frame: 4 months ]
  10. Change from baseline in bone mass density measured with dual energy x-ray absorptiometry (DEXA) at the lumbar spine and hip [ Time Frame: 4 months ]
  11. Change from baseline in the bone turnover marker serum type 1 procollagen (P1NP) [ Time Frame: 4 months ]
  12. Change from baseline in the bone turnover marker serum collagen type 1 cross-linked C-telopeptide (CTX-1) [ Time Frame: 4 months ]
  13. Change from baseline in serum marker of interferon-γ mediated macrophage activation [ Time Frame: 4 months ]
  14. Change from baseline in serum vitamin B6 status. [ Time Frame: 4 months ]
  15. Change from baseline in the glycosylation marker HbA1c [ Time Frame: 4 months ]
  16. Change from baseline in the glycosylation marker the receptor for advanced glycosylation end products (s-RAGE) [ Time Frame: 4 months ]
  17. Change from baseline in the glycosylation marker carboxy-methyllysine [ Time Frame: 4 months ]
  18. Change from baseline in psoriasis Activity in subjects with psoriasis evaluated with the Self-Administered Psoriasis Area Severity Index (SAPASI) [ Time Frame: 4 months ]
  19. Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Dermatological Life Quality Index (DLQI) [ Time Frame: 4 months ]
  20. Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Psoriasis Area Severity Index (PASI) [ Time Frame: 4 months ]
  21. Change from baseline in transcriptomic profile (mRNA) in adipose tissue biopsies [ Time Frame: 4 months ]
  22. Change from baseline in number of subjects with nocturnal legg cramps [ Time Frame: 4 months ]
  23. Change from baseline in sleep pattern evaluated with the Tromsø Study 7th Survey sleep pattern questionnaire [ Time Frame: 4 months ]
  24. Change from baseline in the serum total cholesterol [ Time Frame: 4 months ]
  25. Change from baseline in the serum HDL-cholesterol [ Time Frame: 4 months ]
  26. Change from baseline in the serum LDL-cholesterol [ Time Frame: 4 months ]
  27. Change from baseline in the serum triglycerides [ Time Frame: 4 months ]
  28. Change from baseline in the serum Apolipoprotein A1 [ Time Frame: 4 months ]
  29. Change from baseline in the serum Apolipoprotein B, [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 4 months ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • primary hyperparathyroidism
  • granulomatous disease
  • reduced kidney function
  • systolic blood pressure > 174 mmHg
  • diastolic blood pressure > 104 mmHg
  • diabetes
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750293


Locations
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Norway
University Hospital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University of Tromso
Investigators
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Principal Investigator: rolf Jorde, Professor University of Tromso

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rolf Jorde, Professor, University of Tromso
ClinicalTrials.gov Identifier: NCT02750293     History of Changes
Other Study ID Numbers: TromsøEndo-2013-1
2013-003514-40 ( EudraCT Number )
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not planned

Keywords provided by Rolf Jorde, University of Tromso:
vitamin D
blood pressure
serum lipids
glucose metabolism
muscle function
arterial stiffness
depression
psoriasis
sleep
bone density

Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents