The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors

University of Tromso411 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

411

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolDRUG

Vitamin D preparation

PlaceboDRUG

placebo

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of North Norway

Tromsø, Norway

Outcomes

Primary Outcomes

Change from baseline in systolic and diastolic blood pressure

Time frame: 4 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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