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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

Tracking Information
First Submitted Date  ICMJE April 12, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
Change from baseline in systolic and diastolic blood pressure [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02750293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • Change from baseline in hand-grip, quadriceps and biceps muscle strength measured by hand held dynamometry . [ Time Frame: 4 months ]
  • Change from baseline in score on Becks Depression Inventory [ Time Frame: 4 months ]
  • Change from baseline in cognitive function evaluated with The Twelve Word Memory Test [ Time Frame: 4 months ]
  • Change from baseline in cognitive function evaluated with The Digit Symbol Coding Test [ Time Frame: 4 months ]
  • Change from baseline in cognitive function evaluated with The Tapping Test [ Time Frame: 4 months ]
  • Change from baseline in arterial stiffness and endothelial function evaluated with pulse wave velocity [ Time Frame: 4 months ]
  • Change from baseline in arterial stiffness and endothelial function evaluated with augmentation index (AIX) [ Time Frame: 4 months ]
  • Change from baseline in arterial stiffness and endothelial function evaluated with the subendocardial viability ratio (SEVR) [ Time Frame: 4 months ]
  • Change from baseline in number of subjects with nasal staphylococcus aureus colonization [ Time Frame: 4 months ]
  • 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 ]
  • Change from baseline in the bone turnover marker serum type 1 procollagen (P1NP) [ Time Frame: 4 months ]
  • Change from baseline in the bone turnover marker serum collagen type 1 cross-linked C-telopeptide (CTX-1) [ Time Frame: 4 months ]
  • Change from baseline in serum marker of interferon-γ mediated macrophage activation [ Time Frame: 4 months ]
  • Change from baseline in serum vitamin B6 status. [ Time Frame: 4 months ]
  • Change from baseline in the glycosylation marker HbA1c [ Time Frame: 4 months ]
  • Change from baseline in the glycosylation marker the receptor for advanced glycosylation end products (s-RAGE) [ Time Frame: 4 months ]
  • Change from baseline in the glycosylation marker carboxy-methyllysine [ Time Frame: 4 months ]
  • Change from baseline in psoriasis Activity in subjects with psoriasis evaluated with the Self-Administered Psoriasis Area Severity Index (SAPASI) [ Time Frame: 4 months ]
  • Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Dermatological Life Quality Index (DLQI) [ Time Frame: 4 months ]
  • Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Psoriasis Area Severity Index (PASI) [ Time Frame: 4 months ]
  • Change from baseline in transcriptomic profile (mRNA) in adipose tissue biopsies [ Time Frame: 4 months ]
  • Change from baseline in number of subjects with nocturnal legg cramps [ Time Frame: 4 months ]
  • Change from baseline in sleep pattern evaluated with the Tromsø Study 7th Survey sleep pattern questionnaire [ Time Frame: 4 months ]
  • Change from baseline in the serum total cholesterol [ Time Frame: 4 months ]
  • Change from baseline in the serum HDL-cholesterol [ Time Frame: 4 months ]
  • Change from baseline in the serum LDL-cholesterol [ Time Frame: 4 months ]
  • Change from baseline in the serum triglycerides [ Time Frame: 4 months ]
  • Change from baseline in the serum Apolipoprotein A1 [ Time Frame: 4 months ]
  • Change from baseline in the serum Apolipoprotein B, [ Time Frame: 4 months ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors
Official Title  ICMJE The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors in Subjects With Low Serum 25-hydroxyvitamin D Levels
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Drug: Cholecalciferol
    Vitamin D preparation
    Other Name: Dekristol
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: cholecalciferol
    vitamin D (as a 20 000 IU capsule) will be given once a week for 4 months
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: placebo
    placebo capsules (identical looking to the vitamin D capsules) will be given once a week for 4 months
    Intervention: Drug: Placebo
Publications * Jorde R, Kubiak J, Svartberg J, Fuskevåg 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2017)
411
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
600
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02750293
Other Study ID Numbers  ICMJE TromsøEndo-2013-1
2013-003514-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: not planned
Responsible Party Rolf Jorde, University of Tromso
Study Sponsor  ICMJE University of Tromso
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: rolf Jorde, Professor University of Tromso
PRS Account University of Tromso
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP