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临床试验/NCT03710161
NCT03710161终止4 期

Effect of Vitamin D Supplementation on Balance in Patients With Chronic Kidney Disease

University of Nebraska1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年7月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
5
试验地点
1
主要终点
Fullerton Advanced Balance Scale

研究概览

简要总结

Patients with end-stage renal disease on dialysis (ESRD5D) are 4-5x more likely to suffer from a fracture. Fractures can occur spontaneously but typically occur after a fall. Further, 70-90% of patients with ESRD5D are vitamin D deficient. Vitamin D supplementation has become routine care for many in this patient population, but evidence is lacking to support this practice. The proposed projects objective is to gather needed preliminary data regarding the effects of vitamin D supplementation on balance and muscle strength in patients with ESRD5D.

详细描述

In 2009, ~6% of the annual Medicare budget was spent to treat people with end-stage renal disease on dialysis (ESRD5D), making chronic kidney disease (CKD) an important and costly health problem affecting the United States. These patients are 4-5x more likely to suffer from a fracture. Fractures can occur spontaneously but typically occur after a fall. Further, 70-90% of patients with ESRD5D are vitamin D deficient. Vitamin D supplementation has become routine care for many in this patient population; without evidence to support this practice. While studies on the elderly document the effect of vitamin D in decreasing fall risk, findings are inconclusive for those elderly individuals with ESRD5D. The proposed projects objective is to gather needed preliminary data regarding the effects of vitamin D supplementation on balance and muscle strength in patients with ESRD5D. Thirty patients with ESRD5D will be recruited and randomized into two groups: 1) 4000 or 2) 800 IU oral, vitamin D taken daily. Men and women (ages 21-70 years) will be recruited from among patients receiving hemodialysis at a UNMC-directed dialysis facility. Other inclusion criteria include 1) likely to be able to complete the study; 2) ambulatory, without a walking aid; 3) able to complete questionnaires interactively with a research nurse; and 4) greater than 3 months on hemodialysis. Exclusion criteria include patients on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that would interfere with vitamin D absorption; vitamin D supplements >800 IU per day, glucocorticoids, anticonvulsants, drug therapies for osteoporosis. All patients will be receiving standard of care per their nephrologist. Functional data will be collected at baseline, three, and six months. Data collected will include balance, muscle strength, and falls. Data to monitor vitamin D levels and calcium will be pulled from their medical record. There is no follow up after the six month long study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • must be likely to be able to complete the study
  • must be able to walk without a walking aid
  • must be able to complete questionnaires interactively research staff
  • must have been on dialysis for greater than 3 months
  • all patients must be receiving standard of care per their nephrologist

排除标准

  • peritoneal dialysis
  • an allergy to vitamin D
  • liver disease
  • intestinal disorders that would interfere with vitamin D absorption
  • taking vitamin D supplements >800 IU per day, glucocorticoids, anticonvulsants, or other drug therapies for osteoporosis
  • are pregnant

研究组 & 干预措施

4000 IU Vitamin D

Experimental

4000 IU Vitamin D taken daily for six months

干预措施: Vitamin D (Drug)

800 IU Vitamin D

Active Comparator

800 IU Vitamin D taken daily for six months

干预措施: Vitamin D (Drug)

结局指标

主要结局

Fullerton Advanced Balance Scale

时间窗: Baseline

This 10 item assessment measures one's balance. Scores can range between 0-40. A score of 40 is considered the best performance.

Timed up and go

时间窗: Baseline

This measures fall risk. The measure is a length of time it takes to complete a walking test. A longer score indicates a longer amount of time to complete the test. A shorter amount of time is considered better.

Gait Speed Over 20 Meters

时间窗: Baseline

Walking speed is measured over distance of 20 meters. Walking speed is measured in meters per second. A faster walking speed is considered better. Time in seconds needed to cover 20 meters while walking is reported.

次要结局

  • Strength of the Quadriceps (Right Leg)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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