Evaluation of outcomes from correction of vitamin D levels in residential care facility residents

A randomised, double-blind, placebo controlled cohort study of the benefits of sufficient levels of vitamin D3 as defined by decreasing the number of fractures, acute illnesses and exacerbation of chronic conditions, the need for hospitalisation as well as the mortality rate for permanent residents of residential care facilities.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000950965

Enrollment

250

Registered

2011-09-05

Start date

2011-09-19

Completion date

Unknown

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

The Vitamin D study in ACT Residential Care Facilities (RCFs)will examine whether a maintenance dose of vitamin D3 is effective in improving outcomes such as illness presentations, exacerbations of chronic illness, fractures and death in residents of aged care facilities. The main features of this trial are the assessment of 25(OH)D insufficiency and the commencement of the study drug or a placebo while a control group continues on the usual medications prescribed by thier GPs. After treatment with vitamin D3 or placebo for 12 months, the frequency of unplanned GP visits, hospitalisation, falls and mortality will be assessed.

Interventions

Vitamin D3 - Cholecalciferol 1000IU. Unscored white tablet with D3 on one side. Loading dose of 3000IU daily for six weeks, then 1000IU daily taken daily for 12 months. Total trial period is 58 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

Permenant residents of long-term care facilities in the ACT. Aged 65 years or more. Willing to partipate in the study.

Exclusion criteria

Residents with Aged Care Assesment Team ACFI assessment of 'High' for behaviour (verbal or physical).

Outcome results