Study of fall prevention by vitamin D in the elderly

UMIN ID: UMIN000001831

Registered date:01/04/2009

Basic Information

• Health condition(s) or Problem(s) studied: Patients attending the outpatient clinic at Kyorin University Hospital or other facilities participating in this project, who are at or over the age of 65 years; who have an experience of falling within one year; and whose creatinine clearance is less than 65ml/min by the Cockcroft-Gault formulas
• Date of first enrollment: 2009/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Term: one year Drug: vitamin D (one alpha) Dose: 0.5 ug/day Frequency: every morning
Term: one year Drug: precipitated calcium carbonate (caltan) Dose: 500 mg/day Frequency: every morning

Outcome(s)

• Primary Outcome: Frequency of falls after 6 months and 1 year
• Secondary Outcome: Bone mineral density, bone metabolism markers, neuropsychological function, Fall-related factors such as muscle strength, fall-predicting score

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Bed-ridden patient 2. Patient who has severe liver, GI-tract, or heart disease 3. Parkinson's disease 4. User of a wheel-chair 5. Patient who has paralysis 6. Patient who have a past history of treatment with vitamin D within 6 months 7. Inflammatory degenerative joint disease such as rheumatoid arthritis or osteoarthritis 8. Demented patient who is unable to evaluate a history of falling 9. Patient who has a past history of hypercalcemia or urolithiasis 10. Ineligible patient determined by the attending doctor

Related Information

• Primary Sponsor: Department of Geriatric Medicine, Kyorin University School of Medicine
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare