The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals

Study Overview
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Brief Summary
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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.

Official Title
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The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: cholecalciferol
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cholecalciferol<br>3000 IU cholecalciferol per day for 16 weeks | Dietary Supplement: cholecalciferol<br>* Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks<br>* Other names: D3-Vitamin;|
| Placebo Comparator: placebo<br> | Dietary Supplement: placebo<br>* Empty capsules, 3 capsules per day for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary calcium excretion |  | before and after 16 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25 hydroxyvitamin D |  | before and after 16 weeks og treatment | 
| 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 | 
| pulse wave velocity |  | before and after 16 weeks of 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin d, calcium, blood pressure