A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)

This study has been completed.

Sponsor:

Collaborator:

National Kidney Foundation

Information provided by (Responsible Party):

Mary Schanler, Winthrop University Hospital

ClinicalTrials.gov Identifier:

NCT01114672

First received: April 29, 2010

Last updated: February 15, 2013

Last verified: February 2013

History of Changes

Results First Received: January 8, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Pruritis
Interventions:	Drug: 50,000 Units Ergocalciferol Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult patients undergoing maintenance hemodialysis were recruited from two hemodialysis facilities from 8/11/2010 to 8/1/2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Ergocalciferol	Oral Placebo
STARTED	25	25
COMPLETED	21	23
NOT COMPLETED	4	2
Death	0	1
Withdrawal by Subject	2	1
Lost to Follow-up	1	0
transplanted	1	0

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Ergocalciferol	Oral Placebo	Total
Number of Participants [units: participants]	25	25	50
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	11	13	24
>=65 years	14	12	26
Age [units: years] Mean ± Standard Deviation	66.1 ± 14.7	66.2 ± 13.7	66.2 ± 15.6
Gender [units: participants]
Female	10	11	21
Male	15	14	29
Region of Enrollment [units: participants]
United States	25	25	50

Outcome Measures

1. Primary:

Severity of Pruritis [ Time Frame: Baseline and end of study (up to 12 weeks) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Mary Schanler, Principal Investigator
Organization: Winthrop University Hospital
phone: 5156639028
e-mail: mschanler@winthrop.org

No publications provided

Responsible Party:	Mary Schanler, Winthrop University Hospital
ClinicalTrials.gov Identifier:	NCT01114672 History of Changes
Other Study ID Numbers:	10020
Study First Received:	April 29, 2010
Results First Received:	January 8, 2013
Last Updated:	February 15, 2013
Health Authority:	United States: Institutional Review Board

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