Healthy
Conditions
Keywords
vitamin d, calcium, blood pressure
Brief summary
A randomized placebo controlled trial evaluating the effect of the recently recommended high doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave analysis in healthy individuals.
Interventions
DIETARY_SUPPLEMENTcholecalciferol
Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks
DIETARY_SUPPLEMENTplacebo
Empty capsules, 3 capsules per day for 16 weeks
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \> 18 years old * p 25OH vitaminD\<50nmol/l * signed informed consent
Exclusion criteria
* receiving antihypertensive or antidiabetic treatment * sarcoidoses * history of kidney stones * receiving 1-alfa-hydroxylated vitamin D treatment * plasma creatinin \> 120 micromol/l * ionised calcium \> 1,5 mmol/l * treatment with calcimimetics * active malignancy * intestinal malabsorption * active pancreatitis * former hospitalisation due to alcoholic related disease * using euphoriant drugs * pregnancy or risk of being pregnant or lactating women * Known allergy to cholecalciferol capsules
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urinary calcium excretion | before and after 16 weeks of intervention |
Secondary
| Measure | Time frame |
|---|---|
| 1,25 dihydroxyvitamin D | before and after 16 weeks of treatment |
| urinary creatinin | before and after 16 weeks of treatment |
| urinary protein | before and after 16 weeks of treatment |
| urinary phosphorous | before and after 16 weeks of treatment |
| p-FGF23 | before and after 16 weeks of treatment |
| blood pressure | before and after 16 weeks of treatment |
| 25 hydroxyvitamin D | before and after 16 weeks og treatment |
| augmentation index | before and after 16 weeks of treatment |
| central blood pressure | before and after 16 weeks of treatment |
| p-phosphate | before and after 16 weeks of treatment |
| ionised p-calcium | before and after 16 weeks of treatment |
| p-iPTH | before and after 16 weeks of treatment |
| alkalic phosphatase | before and after 16 weeks of treatment |
| pulse wave velocity | before and after 16 weeks of treatment |
Countries
Denmark
Outcome results
None listed