Loading 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)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001069246

Acronym

LDVD Study

Enrollment

Registered

2009-12-14

Start date

2010-02-01

Completion date

2010-09-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To improve the proportion of elderly patients with moderate to severe vitamin D deficiency reaching target levels above 75nmol/L with the implementation of loading dose vitamin D. The aim is to test the hypotheses: Loading dose cholecalciferol 5000units daily will bring higher proportion of patients with moderate to severe deficiency up to target levels(>75nmol/L) compared to 1000units daily.

Interventions

Patients will be treated with Cholecalciferol 5000units orally daily (five tablets) with 600mg Caltrate(R) orally daily (one tablet) for 12 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Yes

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.

Outcome results