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Trial Outcomes & Findings for Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease (NCT NCT00677534)

NCT ID: NCT00677534

Last Updated: 2014-04-29

Results Overview

Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Change from End of Washout to Week 12

Results posted on

2014-04-29

Participant Flow

Participant milestones

Participant milestones
Measure
Cholecalciferol 50,000 U
Vitamin D
Washout (Weeks 1-4)
STARTED
10
Washout (Weeks 1-4)
COMPLETED
7
Washout (Weeks 1-4)
NOT COMPLETED
3
Cholecalciferol (Weeks 5-12)
STARTED
7
Cholecalciferol (Weeks 5-12)
COMPLETED
7
Cholecalciferol (Weeks 5-12)
NOT COMPLETED
0
After Paricalcitol Restart (Weeks 13-14)
STARTED
7
After Paricalcitol Restart (Weeks 13-14)
COMPLETED
7
After Paricalcitol Restart (Weeks 13-14)
NOT COMPLETED
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Cholecalciferol 50,000 U
Vitamin D
Washout (Weeks 1-4)
did not qualify after signing consent
1
Washout (Weeks 1-4)
Withdrawal by Subject
1

Baseline Characteristics

Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cholecalciferol 50,000 U
n=11 Participants
Vitamin D
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
Region of Enrollment
United States
11 participants
n=5 Participants
Monocyte Vitamin D receptor (VDR) expression
572.7 MFI
STANDARD_DEVIATION 172.3 • n=5 Participants

PRIMARY outcome

Timeframe: Change from End of Washout to Week 12

Population: Clinical pilot trial - proof of concept

Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.

Outcome measures

Outcome measures
Measure
Cholecalciferol 50,000 U
n=7 Participants
Vitamin D
Change in Monocyte VDR Expression With Vitamin D Therapy
1899 units on a scale
Standard Deviation 644.4

Adverse Events

Cholecalciferol 50,000 U

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jason Stubbs

University of Kansas Medical Center

Phone: 913-588-3867

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place