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Effect of Vitamin D on balance performance in elderly fallers.

Effect of Vitamin D on balance performance in elderly fallers. A double blind randomised control trial.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000503224
Acronym
The ViDaBE Study.
Enrollment
60
Registered
2009-06-23
Start date
2009-07-01
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

Vitamin D deficiency becomes more common in the older persons. Vitamin D have been proven to reduce falls. How this benefit is achieved is not clearly known. We suspect that Vitamin D supplementation enhances balance performance in the elderly persons who suffer falls.

Interventions

Patients found to have impaired balance and vitamin D deficiency after assessment in The Nepean Hospital falls and fracture prevention clinic are recruited. Sixty patients (30 cases and 30 controls) fitting the inclusion criteria will be recruited at the Falls and Fractures Clinic, Nepean Hospital. The following parameters will be evaluated at baseline: balance performance measured by our balance rehabilitation unit (BRU), gait parameters (GaitRITE), serum levels of vitamin D, calcium, albumin a

Patients found to have impaired balance and vitamin D deficiency after assessment in The Nepean Hospital falls and fracture prevention clinic are recruited. Sixty patients (30 cases and 30 controls) fitting the inclusion criteria will be recruited at the Falls and Fractures Clinic, Nepean Hospital. The following parameters will be evaluated at baseline: balance performance measured by our balance rehabilitation unit (BRU), gait parameters (GaitRITE), serum levels of vitamin D, calcium, albumin and parathyroid Hormone (PTH). Patients with poor balance performance and low levels of vitamin D will be then randomised to receive either one intramuscular injection dose of vitamin D3 of 50,000 International Units or 1 ml (Arachitol, Solvay Pharma, India) or one intramuscular injection dose of placebo (1 mL of normal saline). All patients will receive calcium 1,200 mg orally once daily for the duration of the study ( 9 weeks) and commences immediately after the vitamin D3/placebo injection. After three weeks of randomization and treatment, all subjects will attend the standard balance rehabilitation program for six weeks. The program is run by a physiotherapist trained in using the balance rehabilitation unit machine. The program consists of two half hour sessions per week and runs for 6 weeks. Once patients complete 6 weeks of BRU, new balance, gait and serological assessment will be performed. Patients will be unblinded when all patients have completed the 6-week assessment. Patients in the placebo will then be supplemented with high dose vitamin D.

Sponsors

The University of Sydney Nepean Medical Research Foundation
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

age 75 or older impaired balance as determined by the BRU Vitamin D level <55.

Exclusion criteria

uncontrolled thyroid disease uncontrolled parathyroid disease parkinsons disease creatinine clearance <35ml/min unable to attend BRU sessions normal BRU parameters

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026