Trial Outcomes & Findings for Effect of Vitamin D Supplementation on Balance in CKD (NCT NCT03710161)
NCT ID: NCT03710161
Last Updated: 2023-12-01
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
Baseline
Results posted on
2023-12-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Study halted due to COVID pandemic
|
3
|
2
|
Baseline Characteristics
Effect of Vitamin D Supplementation on Balance in CKD
Baseline characteristics by cohort
| Measure |
4000 IU Vitamin D
n=3 Participants
4000 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
800 IU Vitamin D
n=2 Participants
800 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Height (cm)
|
174.7 cm
STANDARD_DEVIATION 5.0 • n=5 Participants
|
166.5 cm
STANDARD_DEVIATION 2.5 • n=7 Participants
|
171.7 cm
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Mass (kg)
|
97.0 kg
STANDARD_DEVIATION 21.5 • n=5 Participants
|
112.3 kg
STANDARD_DEVIATION 22 • n=7 Participants
|
103.1 kg
STANDARD_DEVIATION 22.9 • n=5 Participants
|
|
Resting HR
|
69.3 bpm
STANDARD_DEVIATION 12.3 • n=5 Participants
|
69 bpm
STANDARD_DEVIATION 1 • n=7 Participants
|
69.2 bpm
STANDARD_DEVIATION 9.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThis 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.
Outcome measures
| Measure |
4000 IU Vitamin D
n=3 Participants
4000 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
800 IU Vitamin D
n=2 Participants
800 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
|---|---|---|
|
Timed up and go
|
11.4 seconds
Standard Deviation 5.2
|
9.8 seconds
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: BaselineThis 10 item assessment measures one's balance. Scores can range between 0-40. A score of 40 is considered the best performance.
Outcome measures
| Measure |
4000 IU Vitamin D
n=3 Participants
4000 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
800 IU Vitamin D
n=2 Participants
800 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
|---|---|---|
|
Fullerton Advanced Balance Scale
|
25.3 score on a scale
Standard Deviation 6.9
|
34 score on a scale
Standard Deviation 5
|
PRIMARY outcome
Timeframe: BaselineWalking 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.
Outcome measures
| Measure |
4000 IU Vitamin D
n=3 Participants
4000 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
800 IU Vitamin D
n=2 Participants
800 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
|---|---|---|
|
Gait Speed Over 20 Meters
|
22.2 seconds (Time in seconds to walk 20m)
Standard Deviation 6.6
|
20.0 seconds (Time in seconds to walk 20m)
Standard Deviation .7
|
SECONDARY outcome
Timeframe: BaselineMuscle 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.
Outcome measures
| Measure |
4000 IU Vitamin D
n=3 Participants
4000 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
800 IU Vitamin D
n=2 Participants
800 IU Vitamin D taken daily for six months
Vitamin D: Vitamin D taken in two different dosages daily for six months.
|
|---|---|---|
|
Strength of the Quadriceps (Right Leg)
|
58.9 percent body weight
Standard Deviation 39.7
|
55.3 percent body weight
Standard Deviation 16.7
|
Adverse Events
4000 IU Vitamin D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
800 IU Vitamin D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Laura Graeff-Armas
University of Nebraska Medical Center
Phone: 402-559-6310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place