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：
8739913
负责人：
LAWRENCE JOHN APPEL
金额：
$ 99.94万
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/8739913
关键词：
25-hydroxyvitamin D Acute Adult Age Ancillary Study Biometry Black race Blood Calendar Cessation of life Cholecalciferol Clinical Clinical Trials Communities Data Data Collection Databases Deltastab Dietary intake Dose Elderly Eligibility Determination Endocrinology Epidemiology Equilibrium Event Fall prevention Food Fracture Frequencies Gait Gender Geriatric Assessment Guidelines Hospitalization Hypercalcemia Incidence Individual Injury Intake Laboratory Procedures Measures Mediating Memory Metric Multivitamin Nephrolithiasis Outcome Participant Pattern Performance Persons Pharmaceutical Preparations Phase Physical Function Policies Population Population Heterogeneity Probability Procedures Public Health Randomized Recruitment Activity Renal function Reporting Research Infrastructure Research Personnel Safety Sampling Serum Shapes Specific qualifier value Speed Staging Subgroup Supplementation Testing Time Visit Vitamin D Walking Woman aged arm base biobank design experience fall risk falls follow-up frailty high risk meetings muscle strength pill primary outcome public health relevance randomized trial response secondary outcome

25-hydroxyvitamin D Acute Adult Age Ancillary Study Biometry Black race Blood Calendar Cessation of life Cholecalciferol Clinical Clinical Trials Communities Data Data Collection Databases Deltastab Dietary intake Dose Elderly Eligibility Determination Endocrinology Epidemiology Equilibrium Event Fall prevention Food Fracture Frequencies Gait Gender Geriatric Assessment Guidelines Hospitalization Hypercalcemia Incidence Individual Injury Intake Laboratory Procedures Measures Mediating Memory Metric Multivitamin Nephrolithiasis Outcome Participant Pattern Performance Persons Pharmaceutical Preparations Phase Physical Function Policies Population Population Heterogeneity Probability Procedures Public Health Randomized Recruitment Activity Renal function Reporting Research Infrastructure Research Personnel Safety Sampling Serum Shapes Specific qualifier value Speed Staging Subgroup Supplementation Testing Time Visit Vitamin D Walking Woman aged arm base biobank design experience fall risk falls follow-up frailty high risk meetings muscle strength pill primary outcome public health relevance randomized trial response secondary outcome

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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）：老年人跌倒的公共卫生负担很大。几条证据表明，维生素D补充剂可能会大大降低跌倒的风险，在低血清25-羟基维生素D [25（OH）D]水平的患者中可能会降低25％。但是，审判证据不足以指导政策。拟议的研究是一项无缝的，两个阶段的贝叶斯反应自适应随机试验，用于剂量范围和有效性确认。该试验旨在确定补充维生素D的最佳总体剂量，并确认该剂量预防剂量的功效水平。参与者将成为70岁以上的社区居民成年人（黑色约40％，女性约60％），基线血清25（OH）D水平为10-29 ng/ml，他们在上一年至少跌倒了。经过初始的养殖阶段来评估招聘策略并最终确定数据收集程序，参与者将被随机分配给4个维生素D3（胆固醇）测试剂量中的1个：200IU，1000IU，2000IU和4000IU/d。参与者将服用分配的药2年，并再进行1年的延长后续治疗。该设计的第1阶段将选择最佳剂量的维生素D，以预防600万个随访期。对照组（200IU）和最佳剂量组的参与者将继续无缝进入第2阶段，并继续招募所有参与者。主要结果（第2阶段）是在2年治疗中首次跌倒（或死亡）的时候。次要结果是跌倒率，下降的模式，步态速度，平衡，肌肉力量，脆弱，SPPB得分，并且在参与者的样本中，步行时间和加速度计。从参与者每天完成的秋季日历将确定瀑布。后续访问将在3、12、24和36m处进行。具有差异利益潜力的亚组补充维生素D的补充是：a）种族（黑人与其他种族），b）基线维生素D水平（10-19 vs 20-29ng/ml）和c）脆弱状态（脆弱，脆弱，脆弱，不虚弱）。我们的Prven能力招募了包括大量黑人在内的不同人群，使我们能够测试补充维生素D在关键亚组中的影响。该研究的优势包括一组跨学科研究人员，他们在设计，行为，分析和传播临床试验方面具有卓越的往绩，其中许多试验指导了政策。调查团队包括具有维生素D代谢，内分泌学，老年医学，身体机能和跌倒，生物统计学，流行病学，中央实验室程序，适应性设计，社区参与和招聘的人。在我们以前基于社区试验的记录的基础上，我们预计试验结果将及时，严格且与公共卫生指南直接相关，并将立即影响与老年人补充维生素D相关的秋季预防政策。