Effect of Vitamin D Supplementation on Balance in CKD

• ClinicalTrials.gov Identifier: NCT03710161
• Recruitment Status: Terminated
• First Posted: October 18, 2018
• Results First Posted: June 14, 2021
• Last Update Posted: June 14, 2021
• Sponsor: University of Nebraska
• Information provided by (Responsible Party): Jenna Yentes, PhD, University of Nebraska

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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:

Study Protocol and Statistical Analysis Plan  [PDF] April 27, 2021

More Information

• 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
• 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.

• 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:

Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Vitamin D; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents