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）会影响许多老年妇女，并大大降低了生活质量。在美国，老年人最常见的UI类型是紧急UI和混合型UI。用于紧迫性和混合UI的最常见药物类型是一种抗毒性药物。但是，大多数UI药物的患者不会完全干燥，并且由于成本，负面影响或感知效率低下而导致的药物通常会停用。显然，迫切需要对UI的更有效的治疗方法。从流行病学和临床队列研究中提出的证据表明，较低的维生素D水平与UI的风险增加有关，这表明维生素D可能在维持女性的持续性中起作用。由于维生素D的潜在益处可能会扩展到多个器官系统，因此维生素D很可能通过支持骨骼肌强度和正常的凹痕活性来维持延度。在拟议的研究中，我们假设补充维生素D（将血清水平提高到30 ng/ml或更高）将改善维生素D缺乏症的老年女性的UI症状（25（OH）D血清水平小于20 ng/ml）。拟议的双盲，随机，安慰剂对照试验试验的主要目的是估计UI和维生素D缺乏症的老年女性补充维生素D的效果。第二个目的是评估是否改善血清25（OH）D水平会影响其他尿和肠症状。第三个目的是确定可能有助于改善女性亚组的UI症状的潜在机制，包括增加骨盆底骨骼肌力量，降低活性，改善活动性和炎症性尿液生物标志物。招募维生素D缺乏症（n = 100）的绝经后妇女将被招募并随机分配，以接受每周的口服安慰剂或50,000 IU维生素D3（胆固醇）12周。我们的治疗方案旨在达到30 ng/ml或更高的血清25（OH）D水平。 UI肌无端的变化将通过7天的膀胱日记以及其他在基线和12周干预后施用的尿和肠症状的措施来评估。血清钙和25（OH）D水平将在：基线，6周访问以及干预12周结束时进行监测。尿动力学（在研究小组的50％中完成），对骨盆底强度，用于进一步测试的尿液收集和迁移率的评估将在基线和12周进行。预期的结果将提供有关维生素D的影响的新知识。补充UI症状的改善，并为涉及补充维生素D的更大，随机对照临床试验提供信息。