MedPath

oading Dose Vitamin D Study: Cholecalciferol 5000units daily compared to 1000units daily for the treatment of moderate to severe vitamin D deficiency in Elderly Patients (LDVD Study)

Phase 4
Conditions
Elderly Patients with moderate to severe Vitamin D deficiency
Metabolic and Endocrine - Normal metabolism and endocrine development and function
Registration Number
ACTRN12609001069246
Lead Sponsor
Alfred Hosptial
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Stopped early
Sex
All
Target Recruitment
60
Inclusion Criteria

All elderly patients above the age of 65 years old admitted to The Alfred, Caulfield, Sandringham Hospital during study period with moderate to severe vitamin D deficiency (<25nmol/L) with risk factors for osteoporosis as per National Prescribing Service (NPS) guidelines.

Exclusion Criteria

Patients with severe renal dysfunction Estimated Glomerular Filtration Rate (eGFR) less than 10mL/min estimated by Cockcroft Gault formula will be excluded due to their inability to convert cholecalciferol into the activated vitamin D form for use in the body. These patients need to be treated with 1,25 dihydroxyvitamin D.
Patients who have been stabilised on continuous cholecalciferol treatment for more than 6 weeks will be excluded from the trial. Patients who have been on cholecalciferol 1000units or less for a period of less than six weeks treatment would still be considered for enrolment. This is based on the assumption that these patients will not reach steady state due to the long half life of cholecalciferol (~3 weeks).
Patients with swallowing difficulties, currently there are only oral formulations available in Australia therefore it would be not feasible to enrol these patients into the trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath