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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952562
• Other study ID #: 7. juli 2009, version 1
• Status: Completed
• Phase: N/A
• First received: August 3, 2009
• Last updated: August 23, 2011
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Roskilde County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• cholecalciferol
Capsule cholecalciferol 1000 IU, 3 capsules per day for 16 weeks
• placebo
Empty capsules, 3 capsules per day for 16 weeks

Locations

Country	Name	City	State
Denmark	Roskilde Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary calcium excretion		before and after 16 weeks of intervention	Yes
Secondary	25 hydroxyvitamin D		before and after 16 weeks og treatment	No
Secondary	1,25 dihydroxyvitamin D		before and after 16 weeks of treatment	No
Secondary	urinary creatinin		before and after 16 weeks of treatment	No
Secondary	urinary protein		before and after 16 weeks of treatment	No
Secondary	urinary phosphorous		before and after 16 weeks of treatment	Yes
Secondary	p-FGF23		before and after 16 weeks of treatment	No
Secondary	blood pressure		before and after 16 weeks of treatment	No
Secondary	pulse wave velocity		before and after 16 weeks of treatment	No
Secondary	augmentation index		before and after 16 weeks of treatment	No
Secondary	central blood pressure		before and after 16 weeks of treatment	No
Secondary	p-phosphate		before and after 16 weeks of treatment	Yes
Secondary	ionised p-calcium		before and after 16 weeks of treatment	Yes
Secondary	p-iPTH		before and after 16 weeks of treatment	Yes
Secondary	alkalic phosphatase		before and after 16 weeks of treatment	No