Trial Outcomes & Findings for Vitamin D and Arterial Function in Patients With Chronic Kidney Disease (NCT NCT01384539)
NCT ID: NCT01384539
Last Updated: 2018-09-28
Results Overview
EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
128 participants
Primary outcome timeframe
6 months
Results posted on
2018-09-28
Participant Flow
Participant milestones
| Measure |
Cholecalciferol
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol
|
Calcitriol
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
|
Overall Study
COMPLETED
|
58
|
57
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Cholecalciferol
n=64 Participants
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol
|
Calcitriol
n=64 Participants
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 13 • n=99 Participants
|
59 years
STANDARD_DEVIATION 12 • n=107 Participants
|
58 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsEDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.
Outcome measures
| Measure |
Cholecalciferol
n=58 Participants
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol
|
Calcitriol
n=57 Participants
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol
|
|---|---|---|
|
Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.
|
-0.5 percent change in FMD
Standard Deviation 4.2
|
0.3 percent change in FMD
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 6 monthsSecondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation
Outcome measures
| Measure |
Cholecalciferol
n=58 Participants
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol
|
Calcitriol
n=57 Participants
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol
|
|---|---|---|
|
Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein
Baseline
|
3.0 mg/dL
Interval 1.2 to 7.9
|
3.4 mg/dL
Interval 1.5 to 6.7
|
|
Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein
End of Study
|
3.1 mg/dL
Interval 1.7 to 8.3
|
3.9 mg/dL
Interval 0.3 to 2.1
|
SECONDARY outcome
Timeframe: 6 monthsThe effect of calcitriol and cholecalciferol supplementation will be evaluated calculating the mean change in total vascular endothelial cell NFkB expression. NFkB expression is given as arbitrary units and represent ratios of endothelial cell protein expression to human umbilical vein endothelial cell (HUVEC) expression in order to account for any variation in the staining procedure.
Outcome measures
| Measure |
Cholecalciferol
n=58 Participants
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol
|
Calcitriol
n=57 Participants
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol
|
|---|---|---|
|
Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB
|
0.03 ratio of NFkB to HUVEC expression
Standard Deviation 0.1
|
-0.01 ratio of NFkB to HUVEC expression
Standard Deviation 0.1
|
Adverse Events
Cholecalciferol
Serious events: 9 serious events
Other events: 1 other events
Deaths: 2 deaths
Calcitriol
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cholecalciferol
n=64 participants at risk
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol
|
Calcitriol
n=64 participants at risk
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
14.1%
9/64 • Number of events 9
|
7.8%
5/64 • Number of events 5
|
Other adverse events
| Measure |
Cholecalciferol
n=64 participants at risk
Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months
Cholecalciferol
|
Calcitriol
n=64 participants at risk
Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months
Calcitriol
|
|---|---|---|
|
Renal and urinary disorders
Hypercalcemia
|
1.6%
1/64 • Number of events 1
|
6.2%
4/64 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place