Trial Outcomes & Findings for Impact of Vitamin D Therapies on Chronic Kidney Disease (NCT NCT01222234)
NCT ID: NCT01222234
Last Updated: 2016-05-16
Results Overview
Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
8 weeks of therapy
Results posted on
2016-05-16
Participant Flow
Participant milestones
| Measure |
Group 1: Cholecalciferol
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
|
Group 2: Calcitriol
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
calcitriol: calcitriol 0.25 mcg every day
|
Group 3: Cholecalciferol
Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
24
|
|
Overall Study
COMPLETED
|
15
|
15
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Vitamin D Therapies on Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Group 1: Cholecalciferol
n=15 Participants
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
|
Group 2: Calcitriol
n=17 Participants
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
calcitriol: calcitriol 0.25 mcg every day
|
Group 3: Cholecalciferol
n=24 Participants
Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
24 participants
n=5 Participants
|
56 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeks of therapyPopulation: The primary comparison for this outcome was between only CKD groups (groups 1 and 2); therefore data from the non-CKD group (group 3) was not analyzed for this outcome. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.
Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression
Outcome measures
| Measure |
Group 1: Cholecalciferol - CKD
n=15 Participants
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol 50,000 IU twice weekly for 8 weeks
|
Group 2: Calcitriol - CKD
n=15 Participants
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Calcitriol 0.25 mcg every day
|
|---|---|---|
|
Monocyte Protein Expression
ACE
|
1359 relative fluorescence units
Standard Deviation 347.2
|
1360 relative fluorescence units
Standard Deviation 290.8
|
|
Monocyte Protein Expression
VDR
|
2799 relative fluorescence units
Standard Deviation 1210
|
3468 relative fluorescence units
Standard Deviation 3123
|
|
Monocyte Protein Expression
Mac-1
|
14318 relative fluorescence units
Standard Deviation 4196.4
|
14278.5 relative fluorescence units
Standard Deviation 4891.3
|
|
Monocyte Protein Expression
CD14
|
34110 relative fluorescence units
Standard Deviation 9372
|
38540 relative fluorescence units
Standard Deviation 16880
|
PRIMARY outcome
Timeframe: 8 weeks of therapyPopulation: The primary comparison for this outcome of interest was between subjects taking cholecalciferol, so the calcitriol group (group 2) was excluded from the analysis. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.
Outcome measures
| Measure |
Group 1: Cholecalciferol - CKD
n=15 Participants
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol 50,000 IU twice weekly for 8 weeks
|
Group 2: Calcitriol - CKD
n=15 Participants
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Calcitriol 0.25 mcg every day
|
|---|---|---|
|
Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol
|
1.59 ng/ml
Standard Deviation 0.73
|
3.59 ng/ml
Standard Deviation 1.14
|
Adverse Events
Group 1: Cholecalciferol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Calcitriol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3: Cholecalciferol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Cholecalciferol
n=15 participants at risk
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
|
Group 2: Calcitriol
n=17 participants at risk
Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.
calcitriol: calcitriol 0.25 mcg every day
|
Group 3: Cholecalciferol
n=24 participants at risk
Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.
Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week
|
|---|---|---|---|
|
Gastrointestinal disorders
constipation
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/15
|
0.00%
0/17
|
4.2%
1/24 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place