Clinical trial NCT03710161: Effect of Vitamin D Supplementation on Balance in CKD
Official title: Effect of Vitamin D Supplementation on Balance in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Insufficiency, Chronic
Kidney Failure, Chronic
Keywords: dialysis
end stage renal disease
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Timed up and go
timeFrame: Baseline
measure: Fullerton Advanced Balance Scale
timeFrame: Baseline
measure: Gait Speed Over 20 Meters
timeFrame: Baseline
Secondary outcomes:
measure: Strength of the Quadriceps (Right Leg)
timeFrame: Baseline
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska at Omaha
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jenna Yentes, PhD
role: PRINCIPAL_INVESTIGATOR
References: