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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: cholecalciferol; Dietary Supplement: placebo

• Registration Number: NCT00952562
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-23
• Last Update Posted: 2011-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cholecalciferol	cholecalciferol	3000 IU cholecalciferol per day for 16 weeks
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
urinary calcium excretion	before and after 16 weeks of intervention

Secondary Outcome Measures

Name	Time	Method
urinary creatinin	before and after 16 weeks of treatment
25 hydroxyvitamin D	before and after 16 weeks og treatment
1,25 dihydroxyvitamin D	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

Trial Locations

Locations (1)

Roskilde Hospital; 🇩🇰 Roskilde, Denmark