Effect of Vitamin D Supplementation on Balance in CKD



Status:Not yet recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:21 - 70
Updated:10/21/2018
Start Date:December 1, 2018
End Date:December 31, 2019

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

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.


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
We found this trial at
1
site
6001 Dodge Street
Omaha, Nebraska 68182
Principal Investigator: Jenna Yentes, PhD
Phone: 402-554-3251
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mi
from
Omaha, NE
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