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

University of Tromso (UiT)

Status and phase: Completed; Phase 3

Conditions: Vitamin D Deficiency

Treatments: Drug: Placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT02750293

TromsøEndo-2013-1

2013-003514-40 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 411 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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411 participants in 2 patient groups, including a placebo group

cholecalciferol

Active Comparator group

Description:

vitamin D (as a 20 000 IU capsule) will be given once a week for 4 months

Treatment:

Drug: Cholecalciferol

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo