Trial Outcomes & Findings for Vitamin D Supplementation in Kidney Disease (NCT NCT01229878)
NCT ID: NCT01229878
Last Updated: 2025-08-22
Results Overview
Neuromuscular Function - strength testing of hip flexors. Hip flexor strength measured using a push-pull muscle strength dynamometer. Participants performed a hip flexor exercise 3 times at each visit. The final result at each time point was an average of the 3 tries. Outcome measure is change between baseline and 6 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Vitamin D
Hemodialysis Patients randomized to take Vitamin D supplements
Cholecalciferol (Vitamin D): 50,000 units of cholecalciferol administered once a week for 6 months
|
Placebo
Hemodialysis Patients randomized to take placebo pills
Matching placebo pill administered once a week for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
7
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D Supplementation in Kidney Disease
Baseline characteristics by cohort
| Measure |
Vitamin D
n=13 Participants
Hemodialysis Patients randomized to take Vitamin D supplements
Cholecalciferol (Vitamin D): 50,000 units of cholecalciferol administered once a week for 6 months
|
Placebo
n=7 Participants
Hemodialysis Patients randomized to take placebo pills
Placebo pill administered once a week for 6 months
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 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
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
PRIMARY outcome
Timeframe: 6 monthsNeuromuscular Function - strength testing of hip flexors. Hip flexor strength measured using a push-pull muscle strength dynamometer. Participants performed a hip flexor exercise 3 times at each visit. The final result at each time point was an average of the 3 tries. Outcome measure is change between baseline and 6 months.
Outcome measures
| Measure |
Vitamin D
n=10 Participants
Hemodialysis Patients randomized to take Vitamin D supplements
Cholecalciferol (Vitamin D): 50,000 units of cholecalciferol administered once a week for 6 months
|
Placebo
n=6 Participants
Hemodialysis Patients randomized to take placebo pills
Matching placebo pill administered once a week for 6 months
|
|---|---|---|
|
Change in Hip Flexor Strength
|
20.34 percent change
Standard Deviation 34.29
|
6.83 percent change
Standard Deviation 36.44
|
SECONDARY outcome
Timeframe: 6 monthsquestionnaire of physical/medical health
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsbattery of neurocognitive tests
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsassay of immunity markers
Outcome measures
Outcome data not reported
Adverse Events
Vitamin D
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin D
n=13 participants at risk
Hemodialysis Patients randomized to take Vitamin D supplements
Cholecalciferol (Vitamin D): 50,000 units of cholecalciferol once a week for 6 months
|
Placebo
n=7 participants at risk
Hemodialysis Patients randomized to take placebo pills
Placebo pill administered once a week for 6 months
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization
|
23.1%
3/13 • Number of events 3 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
0.00%
0/7 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
|
Cardiac disorders
ER visit
|
0.00%
0/13 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
14.3%
1/7 • Number of events 1 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
|
Psychiatric disorders
Hospitalization
|
7.7%
1/13 • Number of events 1 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
0.00%
0/7 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
|
Injury, poisoning and procedural complications
Prolonged Hospitalization
|
7.7%
1/13 • Number of events 1 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
0.00%
0/7 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
|
Blood and lymphatic system disorders
Hospitalization
|
7.7%
1/13 • Number of events 1 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
14.3%
1/7 • Number of events 1 • 6.5 months - from the time of consent through the 6-month final visit.
Arms/groups are combined for adverse event reporting due to the fluctuation of the vitamin D dosing regime. The dosing regime was adjusted from 50,000 IU to 10,000 IU of vitamin D depending on the participant's measured vitamin D level. If a participant's measured vitamin D level was greater than or equal to 60 ng/ml, the frequency of study drug administration was reduced to once a month instead of once a week. Each participant's timeline for dose adjustment is different.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place