Vitamin D Supplementation in Older Adults with Urinary Incontinence

患有尿失禁的老年人补充维生素 D

基本信息

批准号：
8737887
负责人：
Alayne Denise Markland
金额：
$ 15.48万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-19 至 2017-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8737887
关键词：
25-hydroxyvitamin D Adult Adverse effects Affect Aftercare American Biological Markers Bladder Calcium Case Study Cells Cholecalciferol Clinical Clinical Trials Clinical Trials Design Cohort Analysis Cohort Studies Collection Constipation Data Dietary intake Disease Double-Blind Method Elderly Epidemiologic Studies Epidemiology Fecal Incontinence Frequencies Goals Impaired cognition Inflammation Inflammatory Intervention Intervention Studies Intervention Trial Intestines Knowledge Lead Life Link Longitudinal Studies Measures Monitor Muscarinics Muscle Muscle function National Health and Nutrition Examination Survey Neuraxis Neurologic Nocturia Observational Study Oral Organ Outcome Overactive Bladder Patients Pelvic Floor Muscle Pelvic floor structure Personal Satisfaction Pharmaceutical Preparations Pilot Projects Placebo Control Placebos Play Postmenopause Prevalence Public Health Quality of life Randomized Randomized Controlled Clinical Trials Recruitment Activity Reporting Risk Role Sample Size Series Serum Severities Skeletal Muscle Sphincter Spinal Cord Subgroup Supplementation Symptoms Testing Time Treatment Cost Treatment Protocols Urinary Incontinence Urinary tract infection Urination Urodynamics Visit Vitamin D Vitamin D Deficiency Vitamin D3 Receptor Woman Xerostomia base body system clinical efficacy cost detrusor muscle diaries experience falls functional decline improved improved mobility men muscle strength older women pilot trial public health relevance trend urinary

项目摘要

DESCRIPTION (provided by applicant): Urinary incontinence (UI) affects many older women and greatly reduces quality of life. In the U.S., the most common type of UI in older adults is urgency UI and mixed-type UI. The most common type of medication used for urgency and mixed UI is an antimuscarinic drug. However, most patients on UI medications do not become completely dry and medications are often discontinued due to costs, negative side effects, or perceived inefficacy. Clearly, more efficacious treatments for UI are urgently needed. Evidence emerging from epidemiologic and clinical cohort studies indicates that lower vitamin D levels are associated with increased risk for UI suggesting that vitamin D may have a role in maintaining continence in women. Because the potential benefits of vitamin D may extend to several organ systems, it is quite possible that vitamin D may maintain continence by supporting skeletal muscle strength and normal detrusor activity. In the proposed study, we hypothesize that adequate vitamin D supplementation (raising serum levels to 30 ng/mL or above) will improve UI symptoms in older women with vitamin D deficiency (25(OH)D serum levels less than 20 ng/mL). The primary aim of the proposed double-blind, randomized, placebo-controlled pilot trial is to estimate the effect size of weekly vitamin D supplementation in older women with UI and vitamin D deficiency. The second aim is to evaluate if improving serum 25(OH)D levels affect other urinary and bowel symptoms. The third aim is to identify potential mechanisms that may contribute to improved UI symptoms in a subgroup of women, including increased pelvic floor skeletal muscle strength, decreased detrusor muscle over activity, improved mobility, and inflammatory urinary biomarkers. Post-menopausal women with vitamin D deficiency (n=100) will be recruited and randomized to receive weekly oral placebo or 50,000 IU vitamin D3 (cholecalciferol) for 12 weeks. Our treatment regimen is intended to achieve serum 25(OH)D levels of 30 ng/mL or above. Changes in UI-episodes will be assessed by 7-day bladder diary and other validated measures of urinary and bowel symptoms administered at baseline and after 12-weeks of intervention. Serum calcium and 25(OH)D levels will be monitored at: baseline, 6-week visit, and the end of 12 weeks of the intervention. Urodynamic (done in 50% of the study group), an assessment of pelvic floor strength, urinary collection for further testing, and mobility will be performed at baseline and 12-weeks.The expected outcomes will provide new knowledge regarding the impact of vitamin D supplementation on UI symptom improvement and inform a larger, randomized controlled clinical trial involving vitamin D supplementation.

描述（由申请人提供）：尿失禁（UI）影响许多老年女性并大大降低生活质量。在美国，老年人最常见的 UI 类型是紧急 UI 和混合型 UI。用于紧急情况和混合性 UI 的最常见药物类型是抗毒蕈碱药物。然而，大多数接受 UI 药物治疗的患者并没有完全干燥，并且由于成本、负面副作用或认为无效而经常停止药物治疗。显然，迫切需要更有效的 UI 治疗方法。流行病学和临床队列研究的证据表明，较低的维生素 D 水平与 UI 风险增加相关，这表明维生素 D 可能在维持女性节制方面发挥作用。由于维生素 D 的潜在益处可能延伸至多个器官系统，因此维生素 D 很可能通过支持骨骼肌力量和正常逼尿肌活动来维持节制。在拟议的研究中，我们假设补充足够的维生素 D（将血清水平提高到 30 ng/mL 或以上）将改善维生素 D 缺乏的老年女性（25(OH)D 血清水平低于 20 ng/mL）的 UI 症状。拟议的双盲、随机、安慰剂对照试点试验的主要目的是评估每周补充维生素 D 对患有 UI 和维生素 D 缺乏的老年女性的效果大小。第二个目的是评估血清 25(OH)D 水平的改善是否会影响其他泌尿和肠道症状。第三个目标是确定可能有助于改善女性亚群 UI 症状的潜在机制，包括增加盆底骨骼肌强度、减少逼尿肌过度活动、改善活动能力和炎症性泌尿生物标志物。将招募患有维生素 D 缺乏症的绝经后妇女 (n=100) 并随机接受每周口服安慰剂或 50,000 IU 维生素 D3（胆钙化醇），为期 12 周。我们的治疗方案旨在使血清 25(OH)D 水平达到 30 ng/mL 或以上。 UI 发作的变化将通过 7 天膀胱日记以及在基线和 12 周干预后进行的其他经过验证的泌尿和肠道症状测量来评估。将在以下时间监测血清钙和 25(OH)D 水平：基线、6 周访视和干预 12 周结束时。将在基线和 12 周内进行尿动力学检查（研究组 50% 的人进行）、盆底强度评估、用于进一步测试的尿液收集以及活动能力。预期结果将提供有关维生素 D 影响的新知识补充对UI症状改善的影响，并为涉及补充维生素D的更大规模的随机对照临床试验提供信息。

项目成果

期刊论文数量（2）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Shared Risk Factors for Constipation, Fecal Incontinence, and Combined Symptoms in Older U.S. Adults.

美国老年人便秘、大便失禁和综合症状的共同危险因素。

DOI：
发表时间：
2016
期刊：
影响因子：
6.3
作者：
Andy, Uduak U;Vaughan, Camille P;Burgio, Kathryn L;Alli, Foluke M;Goode, Patricia S;Markland, Alayne D
通讯作者：
Markland, Alayne D

Risk factors associated with lower defecation frequency in hospitalized older adults: a case control study.

与住院老年人排便频率较低相关的危险因素：病例对照研究。