Trial Outcomes & Findings for Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients (NCT NCT01395823)
NCT ID: NCT01395823
Last Updated: 2016-03-14
Results Overview
The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
470 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2016-03-14
Participant Flow
470 subjects were enrolled in the study; however 151 subjects did not make it to randomization due to EPO criteria not met n=45, did not meet other inclusion criteria n=57, no was reason provided n=49. Of the 319 subjects randomized, 43 had a baseline 25(OH)D \>30. This analysis only pertains to the 276 subjects with a baseline 25(OH)D ≤30.
Participant milestones
| Measure |
Ergocalciferol Supplementation
ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
|
Placebo
placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
139
|
|
Overall Study
COMPLETED
|
122
|
130
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
| Measure |
Ergocalciferol Supplementation
ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
|
Placebo
placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
|
|---|---|---|
|
Overall Study
Death
|
4
|
4
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Transplant
|
1
|
0
|
|
Overall Study
GI symptoms
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
Baseline Characteristics
Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Ergocalciferol Supplementation
n=137 Participants
ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
|
Placebo
n=139 Participants
placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
151 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
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 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
|
76 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
92 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
137 participants
n=5 Participants
|
139 participants
n=7 Participants
|
276 participants
n=5 Participants
|
|
25Vit D (ng/mL)
|
16.0 ng/mL
STANDARD_DEVIATION 5.9 • n=5 Participants
|
16.9 ng/mL
STANDARD_DEVIATION 6.4 • n=7 Participants
|
16.4 ng/mL
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Epogen Dose, units/week
|
5800 units/week
n=5 Participants
|
5400 units/week
n=7 Participants
|
5550 units/week
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsThe primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.
Outcome measures
| Measure |
Ergocalciferol Supplementation
n=122 Participants
ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
|
Placebo
n=130 Participants
placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
|
|---|---|---|
|
EPO Dose
EPO dose - Baseline
|
5800 units/week
Interval 2600.0 to 12200.0
|
5400 units/week
Interval 2400.0 to 11500.0
|
|
EPO Dose
EPO dose - 6 months
|
7000 units/week
Interval 2500.0 to 16000.0
|
6050 units/week
Interval 2000.0 to 11800.0
|
Adverse Events
Ergocalciferol Supplementation
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ergocalciferol Supplementation
n=137 participants at risk
ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
|
Placebo
n=139 participants at risk
placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
|
|---|---|---|
|
Cardiac disorders
Death
|
2.9%
4/137 • Number of events 4 • 6 months
|
2.9%
4/139 • Number of events 4 • 6 months
|
Other adverse events
| Measure |
Ergocalciferol Supplementation
n=137 participants at risk
ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
|
Placebo
n=139 participants at risk
placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
6.6%
9/137 • Number of events 9 • 6 months
|
5.8%
8/139 • Number of events 8 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees that the first publication and presentation shall be made by sponsor. If publication is not made within 24 months PI may publish their site data provided that sponsor receives 30 days to review.
- Publication restrictions are in place
Restriction type: OTHER