Monthly Vitamin D to Improve Vitamin D Status and Maintain Function in Pre-frail Older Individuals Living at Home
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- functional decline (proportion of individuals with functional decline based on binary repeated measure assessment across 4 lower extremity tests)
研究概览
简要总结
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.
详细描述
We propose a double-blind, randomized controlled trial to test the effectiveness of a
- Active I (n=70): monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily),
- 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)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High-dose vitamin D3
monthly high-dose vitamin D3 supplement dose (60'000 IU/month, equivalent to 2000 IU daily)
干预措施: ViDe3 (CH) (Dietary Supplement)
standard vitamin D + 25(OH)D
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)
干预措施: Hidroferol® (ES) (Drug)
standard vitamin D
standard vitamin D3 supplement dose (24'000 IU/month, equivalent to 800 IU daily)
干预措施: ViDe3 (CH) (Dietary Supplement)
结局指标
主要结局
functional decline (proportion of individuals with functional decline based on binary repeated measure assessment across 4 lower extremity tests)
时间窗: 6 and 12 months
Improving 25-hydroxyvitamin D levels in late winter and late summer - Percent of individuals reaching desirable 25-hydroxyvitamin D levels of at least 75 nmol/l in late winter and in late summer
时间窗: 6 and 12 months
次要结局
- Safety at baseline, 2 weeks, 6 months, 12 months • Serum calcium adjusted for albumin • Serum creatinine • Urinary calcium/creatinine ratio(2 weeks, 6 months, 12 months)
- Balance/Gait while walking combined with a cognitive task(12 months)
- Short Physical Performance Test Battery(6 months, 12 months)
- Timed 4 m walk(6 months, 12 months)
- Musculoskeletal pain assessed with the McGill pain map(6 months and 12 months)
- Rate of falls, all, injurious falls (diary, monthly phone calls, and hotline)(12 months)
- systolic and diastolic blood pressure, heart rate(6 month and 12 months)
- grip strength(6 months and 12 months)
- Bone density at the spine and hip, whole body(6 months and 12 months)
- incident vertebral fractures (iDXA morphometry)(12 months)
- muscle mass, incident sarcopenia(6 and 12 months)
- Health care utilization: in collaboration with insurance companies for outpatient and inpatient health care costs.(12 months)
- Quality of life (SF 12 / EuroQuol)(6 months and 12 months)
- Rate of hospital admission (fall-related injury, infections, other)(12 months)
- Serum N-telopeptides and other markers of bone remodeling(6 months and 12 months)
- Upper and lower respiratory tract infections, any infections, infections that lead to inpatient care(12 months)