Kidney Failure, Chronic, Renal Insufficiency, Chronic
Conditions
Keywords
dialysis, end stage renal disease
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.
Interventions
DRUGVitamin D
Vitamin D taken in two different dosages daily for six months.
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fullerton Advanced Balance Scale | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Strength of the Quadriceps (Right Leg) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4000 IU Vitamin D 4000 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months. | 3 |
| 800 IU Vitamin D 800 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months. | 2 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study halted due to COVID pandemic | 3 | 2 |
Baseline characteristics
| Characteristic | Total | 4000 IU Vitamin D | 800 IU Vitamin D |
|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 8.1 | 60.3 years STANDARD_DEVIATION 5.7 | 48.5 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height (cm) | 171.7 cm STANDARD_DEVIATION 5.8 | 174.7 cm STANDARD_DEVIATION 5 | 166.5 cm STANDARD_DEVIATION 2.5 |
| Mass (kg) | 103.1 kg STANDARD_DEVIATION 22.9 | 97.0 kg STANDARD_DEVIATION 21.5 | 112.3 kg STANDARD_DEVIATION 22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 5 Participants | 3 Participants | 2 Participants |
| Resting HR | 69.2 bpm STANDARD_DEVIATION 9.5 | 69.3 bpm STANDARD_DEVIATION 12.3 | 69 bpm STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
Fullerton Advanced Balance Scale
This 10 item assessment measures one's balance. Scores can range between 0-40. A score of 40 is considered the best performance.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4000 IU Vitamin D | Fullerton Advanced Balance Scale | 25.3 score on a scale | Standard Deviation 6.9 |
| 800 IU Vitamin D | Fullerton Advanced Balance Scale | 34 score on a scale | Standard Deviation 5 |
Primary
Gait Speed Over 20 Meters
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4000 IU Vitamin D | Gait Speed Over 20 Meters | 22.2 seconds (Time in seconds to walk 20m) | Standard Deviation 6.6 |
| 800 IU Vitamin D | Gait Speed Over 20 Meters | 20.0 seconds (Time in seconds to walk 20m) | Standard Deviation 0.7 |
Primary
Timed up and go
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4000 IU Vitamin D | Timed up and go | 11.4 seconds | Standard Deviation 5.2 |
| 800 IU Vitamin D | Timed up and go | 9.8 seconds | Standard Deviation 1.7 |
Secondary
Strength of the Quadriceps (Right Leg)
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4000 IU Vitamin D | Strength of the Quadriceps (Right Leg) | 58.9 percent body weight | Standard Deviation 39.7 |
| 800 IU Vitamin D | Strength of the Quadriceps (Right Leg) | 55.3 percent body weight | Standard Deviation 16.7 |