Not Yet RecruitingPhase 3ACTRN12609000503224

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.


Sponsor

The University of Sydney Nepean Medical Research Foundation

Enrollment

60 participants

Start Date

Jul 1, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether vitamin D supplements can improve balance in elderly people aged 75 and over who have a history of falls and low vitamin D levels. Participants undergo balance testing before and after supplementation to measure any improvement.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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) f

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.


Locations(1)

Australia

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ACTRN12609000503224