The effect of vitamin D replacement on arterial stiffness in an elderly community based population.

• Conditions: Vitamin D deficiency/insufficiencyArterial stiffness

• Registration Number: EUCTR2010-024417-31-IE
• Lead Sponsor: Beaumont Hospital/RCSI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-19
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Age > 65 years
•Serum 25OHD levels < 50nmol/l
•Not receiving vitamin D preparations
•No change in medications in last 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Age < 65 years
•Renal dysfunction, defined as a creatinine greater than 200µmol/l
•History of or current malignancy
•Known hypoparathyroidism
•Unable to read or give informed consent
•Hypercalcaemia (Corrected calcium > 2.55)
•LFT’s > 3 times the upper limit of normal
•History of renal stones
•Recent (3 months) change in medication
•Hypersensitivity to cholecalciferol or any of its excipients
•Hypervitaminosis D or evidence of vitamin D toxicity
•Contraindications to cholecalciferol as listed in the SPC

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of this clinical trial is to identify whether there is evidence for changes in arterial stiffness after replacement of vitamin D in vitamin D deficient patients.;Secondary Objective: The secondary aim is to compare the efficacy of two different doses of intramuscular vitamin D in providing supplementation and whether there is a difference in their effect on arterial compliance.<br><br>;Primary end point(s): The response of pulse wave velocity to differing doses of vitamin D (Cholecalciferol 100,000IU VS 50,000IU) at 2 months.