NCT01017354

Zurich Disability Prevention Trial

Monthly Vitamin D to Improve Vitamin D Status and Maintain Function in Pre-frail Older Individuals Living at Home

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Community-dwelling Seniors
• History of a Fall in the Previous 12 Months

Interventions

Type	Name	Description
DRUG	Hidroferol® (ES)	24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month
DIETARY_SUPPLEMENT	ViDe3 (CH)	60000 vitamin D3 orally and once per month
DIETARY_SUPPLEMENT	ViDe3 (CH)	24000 Vitamin D3 orally and once per month

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2009-11-20
• Last updated: 2015-08-24

Locations

1 site across 1 country: Switzerland