The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors

Vitamin D Deficiency Clinical Trial

— D-COR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750293
• Other study ID #: TromsøEndo-2013-1
• Secondary ID: 2013-003514-40
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2016
• Last updated: October 24, 2017
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
Vitamin D preparation
• Placebo
placebo

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in systolic and diastolic blood pressure		4 months
Secondary	Change from baseline in hand-grip, quadriceps and biceps muscle strength measured by hand held dynamometry .		4 months
Secondary	Change from baseline in score on Becks Depression Inventory		4 months
Secondary	Change from baseline in cognitive function evaluated with The Twelve Word Memory Test		4 months
Secondary	Change from baseline in cognitive function evaluated with The Digit Symbol Coding Test		4 months
Secondary	Change from baseline in cognitive function evaluated with The Tapping Test		4 months
Secondary	Change from baseline in arterial stiffness and endothelial function evaluated with pulse wave velocity		4 months
Secondary	Change from baseline in arterial stiffness and endothelial function evaluated with augmentation index (AIX)		4 months
Secondary	Change from baseline in arterial stiffness and endothelial function evaluated with the subendocardial viability ratio (SEVR)		4 months
Secondary	Change from baseline in number of subjects with nasal staphylococcus aureus colonization		4 months
Secondary	Change from baseline in bone mass density measured with dual energy x-ray absorptiometry (DEXA) at the lumbar spine and hip		4 months
Secondary	Change from baseline in the bone turnover marker serum type 1 procollagen (P1NP)		4 months
Secondary	Change from baseline in the bone turnover marker serum collagen type 1 cross-linked C-telopeptide (CTX-1)		4 months
Secondary	Change from baseline in serum marker of interferon-? mediated macrophage activation		4 months
Secondary	Change from baseline in serum vitamin B6 status.		4 months
Secondary	Change from baseline in the glycosylation marker HbA1c		4 months
Secondary	Change from baseline in the glycosylation marker the receptor for advanced glycosylation end products (s-RAGE)		4 months
Secondary	Change from baseline in the glycosylation marker carboxy-methyllysine		4 months
Secondary	Change from baseline in psoriasis Activity in subjects with psoriasis evaluated with the Self-Administered Psoriasis Area Severity Index (SAPASI)		4 months
Secondary	Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Dermatological Life Quality Index (DLQI)		4 months
Secondary	Change from baseline in psoriasis Activity in subjects with psoriasis, evaluated with the Psoriasis Area Severity Index (PASI)		4 months
Secondary	Change from baseline in transcriptomic profile (mRNA) in adipose tissue biopsies		4 months
Secondary	Change from baseline in number of subjects with nocturnal legg cramps		4 months
Secondary	Change from baseline in sleep pattern evaluated with the Tromsø Study 7th Survey sleep pattern questionnaire		4 months
Secondary	Change from baseline in the serum total cholesterol		4 months
Secondary	Change from baseline in the serum HDL-cholesterol		4 months
Secondary	Change from baseline in the serum LDL-cholesterol		4 months
Secondary	Change from baseline in the serum triglycerides		4 months
Secondary	Change from baseline in the serum Apolipoprotein A1		4 months
Secondary	Change from baseline in the serum Apolipoprotein B,		4 months
Secondary	Change from baseline in insulin resistance evaluated with the homeostasis model assessment (HOMA) index based on fasting serum glucose and serum insulin		4 months
Secondary	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)		4 months
Secondary	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)		4 months