Trial Outcomes & Findings for A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (NCT NCT01114672)
NCT ID: NCT01114672
Last Updated: 2013-02-21
Results Overview
Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and end of study. The total score ranged from 0-21 with 21 being the most severe and zero being the absence of any of the measures of pruritis. Last observation was carried forward to end of study. A decrease in the Severity of Pruritis score over time indicated an improvement in the severity of pruritis.
COMPLETED
PHASE4
50 participants
Baseline and end of study (up to 12 weeks)
2013-02-21
Participant Flow
Adult patients undergoing maintenance hemodialysis were recruited from two hemodialysis facilities from 8/11/2010 to 8/1/2011.
Three patients failed the screening process due to exclusion criteria: One patient had PTH\<70 pg/mL and two patients had serum phosphorus \>7.0 mg/dL.
Participant milestones
| Measure |
Ergocalciferol
Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
|
Oral Placebo
Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Ergocalciferol
Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
|
Oral Placebo
Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
transplanted
|
1
|
0
|
Baseline Characteristics
A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Ergocalciferol
n=25 Participants
Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
|
Oral Placebo
n=25 Participants
Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age Continuous
|
66.1 years
STANDARD_DEVIATION 14.7 • n=99 Participants
|
66.2 years
STANDARD_DEVIATION 13.7 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 15.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of study (up to 12 weeks)Population: Number randomized in each arm 25
Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and end of study. The total score ranged from 0-21 with 21 being the most severe and zero being the absence of any of the measures of pruritis. Last observation was carried forward to end of study. A decrease in the Severity of Pruritis score over time indicated an improvement in the severity of pruritis.
Outcome measures
| Measure |
Ergocalciferol
n=25 Participants
Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
|
Oral Placebo
n=25 Participants
Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
|
|---|---|---|
|
Severity of Pruritis
Baseline
|
10.88 units on a scale
Standard Deviation 5.15
|
9.76 units on a scale
Standard Deviation 5.34
|
|
Severity of Pruritis
End of study
|
6.64 units on a scale
Standard Deviation 6.14
|
5.12 units on a scale
Standard Deviation 4.24
|
Adverse Events
Ergocalciferol
Oral Placebo
Serious adverse events
| Measure |
Ergocalciferol
n=25 participants at risk
Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
|
Oral Placebo
n=25 participants at risk
Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroparesis
|
4.0%
1/25 • Number of events 1 • 15 months
Only serious adverse events were intended to be collected in this study
|
0.00%
0/25 • 15 months
Only serious adverse events were intended to be collected in this study
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • 15 months
Only serious adverse events were intended to be collected in this study
|
4.0%
1/25 • Number of events 1 • 15 months
Only serious adverse events were intended to be collected in this study
|
|
Hepatobiliary disorders
Abdominal distension
|
0.00%
0/25 • 15 months
Only serious adverse events were intended to be collected in this study
|
4.0%
1/25 • Number of events 1 • 15 months
Only serious adverse events were intended to be collected in this study
|
|
Hepatobiliary disorders
Cirrhosis
|
0.00%
0/25 • 15 months
Only serious adverse events were intended to be collected in this study
|
4.0%
1/25 • Number of events 1 • 15 months
Only serious adverse events were intended to be collected in this study
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
0.00%
0/25 • 15 months
Only serious adverse events were intended to be collected in this study
|
4.0%
1/25 • Number of events 1 • 15 months
Only serious adverse events were intended to be collected in this study
|
|
Hepatobiliary disorders
Death
|
0.00%
0/25 • 15 months
Only serious adverse events were intended to be collected in this study
|
4.0%
1/25 • Number of events 1 • 15 months
Only serious adverse events were intended to be collected in this study
|
|
Cardiac disorders
Hypotension
|
0.00%
0/25 • 15 months
Only serious adverse events were intended to be collected in this study
|
4.0%
1/25 • Number of events 1 • 15 months
Only serious adverse events were intended to be collected in this study
|
Other adverse events
Adverse event data not reported
Additional Information
Mary Schanler, Principal Investigator
Winthrop University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place