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
Conditions
Interventions
Trade Name: Dekristol
Product Name: Dekristol
Product Code: vitamin
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral us
Sponsors
University Hospital of North Norway
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: males and females 20 - 80 yearts participated in the 7th Tromsø study low serum 25OHD (=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Difference in change in muscle strength (hand-grip, quadriceps, biceps) after three months - Difference in BDI score after three months - Difference in cognitive function tests after three months - Difference in PWV, augmentation index (AIX), and subendocardial viability ratio (SEVR) after three months ;Timepoint(s) of evaluation of this end point: at end of study after 3 months | — |
Countries
Norway
Contacts
Public ContactRolf Jorde
University Hospital of North Norway
Outcome results
None listed