Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response Trial

补充维生素 D 预防老年人跌倒：剂量反应试验

基本信息

批准号：
9462039
负责人：
LAWRENCE JOHN APPEL
金额：
$ 173.12万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-01 至 2020-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9462039
关键词：
25-hydroxyvitamin D Accelerometer Acute Adult Age Ancillary Study Biometry Blood Calendar Cessation of life Cholecalciferol Clinical Clinical Trials Communities Data Data Collection Databases Dietary intake Dose Elderly Eligibility Determination Endocrinology Epidemiology Equilibrium Event Fall prevention Food Fracture Frequencies Gait speed Gender Geriatrics Guidelines Hospitalization Hypercalcemia Incidence Individual Injury Intake Laboratory Procedures Measures Mediating Memory Multivitamin Nephrolithiasis Outcome Participant Pattern Persons Pharmaceutical Preparations Phase Physical Function Physical Performance Physical assessment Policies Population Heterogeneity Probability Procedures Public Health Race Randomized Renal function Reporting Research Infrastructure Research Personnel Safety Sampling Serum Shapes Specific qualifier value Subgroup Supplementation Testing Time Visit Vitamin D Vitamin D supplementation Walking Woman aged arm base biobank design experience fall risk falls follow-up frailty high risk high risk population meetings muscle strength pill primary outcome public health relevance randomized trial recruit reduced muscle strength response secondary outcome

项目摘要

DESCRIPTION (provided by applicant): The public health burden of falls in older persons is substantial. Several lines of evidence suggest that vitamin D supplements might substantially reduce the risk of falls, potentially by > 25% in persons with low serum 25-hydroxyvitamin D [25(OH)D] levels. However, trial evidence is insufficient to guide policy. The proposed study is a seamless, two stage, Bayesian response-adaptive randomized trial for dose-ranging and efficacy confirmation. The trial is designed to identify the best overall dose of vitamin D supplementation and confirm the level of efficacy of that dose for fall prevention. Participants wil be community-dwelling adults, aged 70+ (~40% black, ~60% women), with a baseline serum 25(OH)D level of 10-29 ng/ml, who report at least one fall in the prior year. After an initial pilt phase to evaluate recruitment strategies and finalize data collection procedures, participants will be randomly assigned to 1 of 4 vitamin D3 (cholecalciferol) test doses: 200IU, 1000IU, 2000IU and 4000IU/d. Participants will take their assigned pills for 2 years with extended follow-up off therapy for 1 more year. Stage 1 of this design will select the best dose of vitamin D for prevention of falls over a 6m follow-up period. Participants in the control (200IU) and best dose group will continue seamlessly into Stage 2 with additional recruitment and continued follow-up of all participants. The principal outcome (Stage 2) is time to first fall (or death) over 2 years f therapy. Secondary outcomes are fall rates, patterns of falling, gait speed, balance, muscle strength, frailty, SPPB score, and, in a sample of participants, 400m walk time and accelerometry. Falls will be ascertained from fall calendars completed daily by participants. Follow-up visits will occur at 3, 12, 24 and 36m. Subgroups with potential for differential benefit from vitamin D supplementation are pre- specified as: a) race (blacks vs others), b) baseline vitamin D levels (10-19 vs 20-29ng/ml), and c) frailty status (frail, pre-frail, not frail). Our prven capacity to recruit a diverse population, including large numbers of blacks, allows us to test the effects of vitamin D supplementation in key subgroups. Strengths of the study include a team of interdisciplinary investigators who have vast experience and an exceptional track record in the design, conduct, analysis and dissemination of clinical trials, many of which have guided policy. The investigative team includes individuals with expertise in vitamin D metabolism, endocrinology, geriatrics, assessment of physical function and falls, biostatistics, epidemiology, central laboratory procedures, adaptive designs, community engagement, and recruitment. Building on our record in previous community-based trials, we expect that trial results will be timely, rigorous, and directly relevant to public health guidelines and will immediately influence fall prevention policies related to vitamin D supplementation in older persons.

描述（由申请人提供）：老年人跌倒造成的公共卫生负担是巨大的。多项证据表明，维生素 D 补充剂可能会显着降低跌倒风险，对于血清 25-羟基维生素 D [25(OH)D] 水平较低的人来说，跌倒风险可能降低 > 25%。然而，审判证据不足以指导政策。拟议的研究是一项无缝的、两阶段的、贝叶斯响应适应性随机试验，用于剂量范围和疗效确认。该试验旨在确定补充维生素 D 的最佳总体剂量，并确认该剂量预防跌倒的功效水平。参与者将是居住在社区的成年人，年龄在 70 岁以上（约 40% 是黑人，约 60% 是女性），基线血清 25(OH)D 水平为 10-29 ng/ml，并且报告在之前至少有过一次跌倒经历。年。在评估招募策略并最终确定数据收集程序的初始试验阶段后，参与者将随机分配至 4 种维生素 D3（胆钙化醇）测试剂量中的 1 种：200IU、1000IU、2000IU 和 4000IU/d。参与者将服用指定的药物 2 年，并延长治疗后随访 1 年。该设计的第一阶段将选择维生素 D 的最佳剂量，以在 6 m 的随访期内预防跌倒。对照组（200IU）和最佳剂量组的参与者将通过额外招募和对所有参与者的持续随访无缝地进入第二阶段。主要结果（第 2 阶段）是治疗 2 年内首次跌倒（或死亡）的时间。次要结果是跌倒率、跌倒模式、步态速度、平衡、肌肉力量、虚弱程度、SPPB 评分，以及参与者样本中的 400m 步行时间和加速度测量。跌倒将根据参与者每天填写的秋季日历来确定。后续访问将在 3、12、24 和 36m 进行。具有差异效益潜力的亚组补充维生素 D 的结果预先指定为：a) 种族（黑人与其他人），b) 基线维生素 D 水平（10-19 与 20-29 ng/ml），以及 c) 虚弱状态（虚弱、虚弱前、非虚弱状态）脆弱）。我们拥有招募多元化人群（包括大量黑人）的能力，这使我们能够测试补充维生素 D 对关键亚群的效果。该研究的优势包括由跨学科研究人员组成的团队，他们在临床试验的设计、实施、分析和传播方面拥有丰富的经验和出色的记录，其中许多临床试验指导了政策。调查团队包括在维生素 D 代谢、内分泌学、老年病学、身体机能和跌倒评估、生物统计学、流行病学、中心实验室程序、适应性设计、社区参与和招募方面具有专业知识的个人。基于我们之前社区试验的记录，我们预计试验结果将是及时、严格且与公共卫生指南直接相关的，并将立即影响与老年人补充维生素 D 相关的跌倒预防政策。