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Completed

NCT Number: NCT02750293

The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Cholecalciferol

Drug

Vitamin D preparation

Other names: Dekristol

Placebo

Drug

placebo

Primary outcomes

  1. Change from baseline in systolic and diastolic blood pressure

    Time frame: 4 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Registry information

Official study title

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

Acronym: D-COR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2016
Registry last updated
Oct 26, 2017

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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