Vitamin D Repletion in Chronic Kidney Disease

This study has been completed.

Study NCT00772772 Information provided by Rockefeller University

First Received on October 13, 2008. Last Updated on May 11, 2011 History of Changes

Results First Received: March 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chronic Kidney Disease
Intervention:	Drug: Vitamin D3

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
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Pre-Assignment Details

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

	Description
Vitamin D3	No text entered.

Participant Flow: Overall Study

	Vitamin D3
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Vitamin D3	No text entered.

Baseline Measures

	Vitamin D3
Number of Participants [units: participants]	12
Age [units: years] Mean ± Standard Deviation	61 ± 7
Gender [units: participants]
Female	6
Male	6
Region of Enrollment [units: participants]
United States	12

Outcome Measures

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1. Primary:

Change in Endotoxin Activity [ Time Frame: baseline and 8 weeks ]

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2. Secondary:

25-hydroxy Vitamin D (25-OH Vitamin D) [ Time Frame: after 8 weeks of vitamin D therapy ]

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3. Secondary:

Blood Pressure [ Time Frame: after 8 weeks of vitamin D therapy ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Intestinal Permeability [ Time Frame: after 8 weeks of vitamin D therapy ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Nuclear Magnetic Resonance (NMR) Lipoprotein Profile [ Time Frame: after 8 weeks of vitamin D therapy ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

6. Secondary:

1, 25-OH Vitamin D [ Time Frame: after 8 weeks of vitamin D therapy ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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: Dr. Mansih Ponda
Organization: The Rockefeller University
phone: 212-327-7631
e-mail: mponda@rockefeller.edu

No publications provided

Responsible Party:	Manish Ponda, MD, Rockefeller University
ClinicalTrials.gov Identifier:	NCT00772772 History of Changes
Other Study ID Numbers:	MAP-0626
Study First Received:	October 13, 2008
Results First Received:	March 10, 2011
Last Updated:	May 11, 2011
Health Authority:	United States: Institutional Review Board