Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Number of Acute Respiratory Infections (ARIs)
研究概览
简要总结
This study will test the role of high dose vitamin D supplementation in prevention of acute respiratory infection in older nursing home residents. The investigators hypothesize that residents on high dose vitamin D supplementation will have a lower incidence of acute respiratory infection that those on standard dose vitamin D supplementation.
详细描述
This study is a double-blinded, parallel group, randomized controlled phase II trial of oral high vs. standard dose vitamin D3 supplementation administered monthly for 12 months.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60+ years
- •Resides in nursing home
排除标准
- •Terminal illness (expected survival <6 months)
- •Anticipated discharge within 12 months
- •Unable to take whole or crushed tablets
- •Active cancer, except squamous/basal cell carcinoma
- •Severe malnutrition (body mass index <18 kg/m2)
- •Current immunosuppressive medications (including corticosteroids)
- •Renal failure (estimated glomerular filtration rate < 15 mL/min/1.73m2)
- •Currently taking >1,000 IU/d vitamin D supplementation
- •History (or strong family history) of kidney stones
- •History of sarcoidosis or other granulomatous disorders associated with hypercalcemia
- •Elevated baseline hypercalcemia (albumin-adjusted serum calcium >10.5 mg/dL)
- •Baseline serum 25OHD level ≥ 100 nmol/L
- •Inability to provide informed consent and no available healthcare legally authorized representative
- •Inability of participant or legally authorized representative to speak/understand English
研究组 & 干预措施
High Dose Vitamin D
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
干预措施: High Dose Vitamin D (Drug)
High Dose Vitamin D
100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
干预措施: Usual Care (Dietary Supplement)
Standard Dose Vitamin D
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
干预措施: Standard Dose Vitamin D (Drug)
Standard Dose Vitamin D
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
干预措施: Placebo (Drug)
Standard Dose Vitamin D
12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
干预措施: Usual Care (Dietary Supplement)
结局指标
主要结局
Number of Acute Respiratory Infections (ARIs)
时间窗: 12 months
ARIs defined as upper or lower respiratory infections
次要结局
- Severity of Acute Respiratory Infections(12 month)
- Time to First ARI(12 months)
- Change in 25-hydroxyvitamin D (25OHD) Level(Baseline and 12 months)
- Change in Parathyroid Hormone Level(Baseline and 12 months)
- Fractures(12 months)
- Falls(12 months)
- Number of Upper Respiratory Infections(12 months)
- Number of Lower Respiratory Infections(12 months)
- Number of Influenza-like Illnesses(12 months)
- Incident Kidney Stones(12 months)
- Incident Hypercalcemia(12 months)
- Death(12 months)
- Number of Urinary Tract Infections(12 months)
- Number of Other Infections(12 months)