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Effect of Vitamin D Supplementation on Balance in CKD

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ClinicalTrials.gov Identifier: NCT03710161
Recruitment Status : Terminated (Study was stopped due to the COVID pandemic)
First Posted : October 18, 2018
Results First Posted : June 14, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Jenna Yentes, PhD, University of Nebraska

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Kidney Failure, Chronic Drug: Vitamin D Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Supplementation on Balance in Patients With Chronic Kidney Disease
Actual Study Start Date : July 8, 2019
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: 4000 IU Vitamin D
4000 IU Vitamin D taken daily for six months
Drug: Vitamin D
Vitamin D taken in two different dosages daily for six months.
Other Name: 25(OH)D

Active Comparator: 800 IU Vitamin D
800 IU Vitamin D taken daily for six months
Drug: Vitamin D
Vitamin D taken in two different dosages daily for six months.
Other Name: 25(OH)D




Primary Outcome Measures :
  1. Timed up and go [ Time Frame: 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.

  2. Fullerton Advanced Balance Scale [ Time Frame: Baseline ]
    This 10 item assessment measures one's balance. Scores can range between 0-40. A score of 40 is considered the best performance.

  3. Gait Speed Over 20 Meters [ Time Frame: 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.


Secondary Outcome Measures :
  1. Strength of the Quadriceps (Right Leg) [ Time Frame: Baseline ]
    Muscle strength of the muscles in the thigh will be measured using an isokinetic dynamometer. Strength is measured by the amount of force (peak torque) and will be divided by body mass (kg). Strength is reported as a percent of body weight. A greater peak torque percentage is considered better.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710161


Locations
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United States, Nebraska
University of Nebraska at Omaha
Omaha, Nebraska, United States, 68182
Sponsors and Collaborators
University of Nebraska
  Study Documents (Full-Text)

Documents provided by Jenna Yentes, PhD, University of Nebraska:
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Responsible Party: Jenna Yentes, PhD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03710161    
Other Study ID Numbers: 608-18-FB
First Posted: October 18, 2018    Key Record Dates
Results First Posted: June 14, 2021
Last Update Posted: June 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De -identified data will be published as supplementary data to manuscripts.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jenna Yentes, PhD, University of Nebraska:
dialysis
end stage renal disease
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents