A Phase 4 interventional study of Vitamin D in Renal Insufficiency, Chronic and Kidney Failure, Chronic, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by University of Nebraska · Phase 4, Interventional, and Treatment
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.
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 5 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
4000 IU Vitamin D taken daily for six months
Drug: 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.
Also known as: 25(OH)D
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
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
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
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
| Milestone | 4000 IU Vitamin D | 800 IU Vitamin D |
|---|---|---|
| Started | 3 | 2 |
| Completed | 0 | 0 |
| Not completed | 3 | 2 |
| Withdrew: Study halted due to covid pandemic | 3 | 2 |
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.
| seconds | 4000 IU Vitamin D | 800 IU Vitamin D |
|---|---|---|
| Timed up and go | 11.4 ± 5.2 | 9.8 ± 1.7 |
This 10 item assessment measures one's balance. Scores can range between 0-40. A score of 40 is considered the best performance.
| score on a scale | 4000 IU Vitamin D | 800 IU Vitamin D |
|---|---|---|
| Fullerton Advanced Balance Scale | 25.3 ± 6.9 | 34 ± 5 |
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.
| seconds (Time in seconds to walk 20m) | 4000 IU Vitamin D | 800 IU Vitamin D |
|---|---|---|
| Gait Speed Over 20 Meters | 22.2 ± 6.6 | 20.0 ± .7 |
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.
| percent body weight | 4000 IU Vitamin D | 800 IU Vitamin D |
|---|---|---|
| Strength of the Quadriceps (Right Leg) | 58.9 ± 39.7 | 55.3 ± 16.7 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4000 IU Vitamin D | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| 800 IU Vitamin D | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | 4000 IU Vitamin D | 800 IU Vitamin D | Total |
|---|---|---|---|
| Mean | 60.3 ± 5.7 | 48.5 ± 5.5 | 55.6 ± 8.1 |
| Sex: Female, Male(Participants) | 4000 IU Vitamin D | 800 IU Vitamin D | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | 4000 IU Vitamin D | 800 IU Vitamin D | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 3 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 4000 IU Vitamin D | 800 IU Vitamin D | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 0 | 1 | 1 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 4000 IU Vitamin D | 800 IU Vitamin D | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
| Height (cm)(cm) | 4000 IU Vitamin D | 800 IU Vitamin D | Total |
|---|---|---|---|
| Mean | 174.7 ± 5.0 | 166.5 ± 2.5 | 171.7 ± 5.8 |
| Mass (kg)(kg) | 4000 IU Vitamin D | 800 IU Vitamin D | Total |
|---|---|---|---|
| Mean | 97.0 ± 21.5 | 112.3 ± 22 | 103.1 ± 22.9 |
| Resting HR(bpm) | 4000 IU Vitamin D | 800 IU Vitamin D | Total |
|---|---|---|---|
| Mean | 69.3 ± 12.3 | 69 ± 1 | 69.2 ± 9.5 |
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Plan to share: No — De -identified data will be published as supplementary data to manuscripts.
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Studies of the drug tested here: Vitamin D
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