Trial of Vitamin D Supplementation and Neuromuscular Function in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months
研究概览
简要总结
The purpose of this study is to see if vitamin D supplementation improves muscle function in older adults.
详细描述
This study is a 12-month, double-blind randomized placebo controlled trial in older (65-89 yrs) men and women with initial 25(OH)D concentrations of 18-<30 ng/mL to determine the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on 1) change in neuromuscular functions that are established risk-factors for falls in older adults; and 2) changes in the underlying physiological mechanisms over 4 months in a subset of randomly selected participants. Participants will be randomized to 2000 IU/d of vitamin D3 or placebo. Lower extremity muscle strength and power, physical performance, and postural sway will be assessed at baseline, 4 months and 12 months and falls assessed monthly. Muscle biopsies of the vastus lateralis will be taken at baseline and 4 months to assess muscle fiber type, contractility, and denervation, and number and differentiation stage of satellite cells.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥65 to <90 years
- •SPPB <=10
- •Initial serum 25(OH)D concentration of 18 to <30 ng/mL
- •Not dependent on a walker
- •Able to provide own transportation to study visits
- •Not involved in another intervention study
- •Willing to provide informed consent and adhere to the protocol
排除标准
- •Serious or uncontrolled chronic disease including: insulin-dependent diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; acute coronary event (within the last 6 months), uncontrolled angina, heart failure (stage 3-4), PAD, or stroke (within the last 6 months); uncontrolled hypertension (BP>200/110 mmHg); chronic respiratory disease requiring the use of oxygen; uncontrolled endocrine/metabolic disease; neurological (e.g., Parkinson's disease) or hematological disease; liver or renal dysfunction (eGFR <45 mL/min/1.73m2); and musculoskeletal impairments severe enough to preclude functional testing
- •Evidence of impaired cognitive function (MoCA <18)
- •Taking prescription vitamin D2 or taking >1000 IU/day of vitamin D3 (from all sources); taking an oral corticosteroid (i.e., prednisone at 7.5mg/d for 3 mos or equivalent); taking hormone replacement therapy
- •Inability or contraindications to consume daily vitamin D supplements (e.g., hypercalcemia, sarcoidosis, history of kidney stones in last 5 years)
- •Knee or hip surgery within the last 6 months or planned knee or hip surgery within the next year
- •Unwillingness to undergo a muscle biopsy or use of anti-coagulants
- •Unintentional weight loss of ≥5% or more in the past 3 months
- •BMI >40 kg/m2
- •If the PI feels the participant is unlikely to follow the protocol
结局指标
主要结局
Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months
时间窗: over 4 months of follow-up
This will be examined in muscle biopsies collected at baseline and 4-month follow-up using the ATPase, pH 9.4 technique, combined with laminin immunostaining in 10 micrometer muscle sections and the number of type I and type II fiber subtypes quantified. The percentage of type II fibers is calculated by dividing the number of type II fibers by the sum of type I and type II fibers combined.
Change in Lower Extremity Muscle Power Over 12 Months
时间窗: change from baseline at 12 month follow-up reported
Lower extremity muscle power will be measured at baseline, 4- and 12-month follow-up using the Nottingham Power Rig. Participants sit in a chair and unilaterally depress a foot lever attached to a flywheel as hard and as fast as they can. Power output, derived from the acceleration of the flywheel from 5 trials on each leg at maximal effort, will be recorded in Watts. Maximum leg power at baseline (from either the right or left leg) and the maximum power from the same leg at 4- and 12-month follow-up will be used in all analyses. Leg power (Watts) will be standardized to total body mass (in Kg).
次要结局
- Change in Lower Extremity Muscle Strength Over 12 Months(change from baseline at 12 month follow-up reported)
- Change in Maximum Mediolateral (ML) Displacement Over 12 Months(change from baseline at 12 month follow-up reported)
- Change in the Short Physical Performance Battery (SPPB) Score Over 12 Months(change from baseline at 12 month follow-up reported)
- Change in the Expanded Physical Performance Battery Score Over 12 Months(change from baseline at 12 month follow-up reported)
- Change in Timed Up and Go (TUG) Over 12 Months(change from baseline at 12 month follow-up reported)
- Change in Average Sway Velocity Over 12 Months(change from baseline at 12 month follow-up reported)
- Change in 95% Confidence Ellipse Area Over 12 Months(change from baseline at 12 month follow-up reported)
- Change in Maximum Anteroposterior (AP) Displacement Over 12 Months(change from baseline at 12 month follow-up reported)