The effect of vitamin D supplementation on cardiovascular risk factors in subjects with low serum 25-hydroxyvitamin D levels

Conditions: subjects with serum 25-hydroxyvitamin D < 35 nmol/L will be included and the effect of vitamin D supplementation versus placebo tested regarding cardiovascular risk factors
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2013-003514-40-NO

Lead Sponsor: niversity Hospital of North Norway

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

males and females 20 - 80 yearts
participated in the 7th Tromsø study
low serum 25OHD (< 35 nmol/L)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

-subjects allergic to nuts (the study capsules contain peanut oil)
-subjects with primary hyperparathyroidism
-granulomatous diseases (sarcoidosis, tuberculosis, Wegner’s granulomatosis)
-reduced kidney function (creatinine > 130 µmol/L in males and 120 µmol/L in females)
-systolic BP > 174 mmHg, diastolic BP > 104 mmHg,
-diabetes (fasting blood glucose > 6.9 mmol/L and/or HbA1c > 6.5 %)
-renal stones the last 5 years
-subjects who use solarium on a regular basis (more than twice a month on average)
-subjects who plan holiday(s) in tropical areas (or Mediterranean during the summer months) for more than two weeks
-subjects with BDI score higher than 29
-subjects with clinical signs of proximal myopathy (problems with standing up from chair or walking stairs)
-subjects seriously ill and unfit for participation in a clinical study (as judged by one of the study doctors)
-subjects using vitamin D supplements exceeding 800 IU per day or active vitamin D drugs (Rocaltrol or Etalpha)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To see the effect of vitamin D supplementatin on cardiovascular risk factors;Secondary Objective: To see the effect of vitamin D supplementatin on cardiovascular risk factors;Primary end point(s): The primary endpoints will be the difference in change between the vitamin D and placebo group in CVD risk factors (BP, lipid profile, insulin resistance) after three months.;Timepoint(s) of evaluation of this end point: at end of study after 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Difference in change in muscle strength (hand-grip, quadriceps, biceps) after three months<br>-Difference in BDI score after three months<br>-Difference in cognitive function tests after three months<br>-Difference in PWV, augmentation index (AIX), and subendocardial viability ratio (SEVR) after three months<br>;Timepoint(s) of evaluation of this end point: at end of study after 3 months