Community-dwelling Seniors Clinical Trial
Official title:
Monthly Vitamin D to Improve Vitamin D Status and Maintain Function in Pre-frail Older Individuals Living at Home
This project was designed to optimizing vitamin D status in prefrail seniors age 70+ living at home and prevent their functional decline. We test 3 arms of monthly vitamin D supplementation. Intermittent dosing will improve adherence and simplify vitamin D supplementation.
We propose a double-blind, randomized controlled trial to test the effectiveness of a
1. Active I (n=70): monthly high-dose vitamin D3 supplement dose (60'000 IU/month,
equivalent to 2000 IU daily),
2. Active II (n=70): or a monthly standard vitamin D3 supplement dose combined with
25(OH)D (24'000 IU/month, equivalent to 800 IU daily PLUS 300 mcg 25(OH)D, equivalent
to 10 mcg per day)
3. Control (n=70): compared to a standard vitamin D3 supplement dose (24'000 IU/month,
equivalent to 800 IU daily)
All individuals will be advised to consume calcium from natural food sources in a daily dose
of 600-800 mgs a day, including milk products. Maximal intake of supplemental calcium is
restricted to 250 mg per day.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention