Vitamin D Repletion in Chronic Kidney Disease
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| Tracking Information | |||||
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| First Received Date ICMJE | October 13, 2008 | ||||
| Last Updated Date | May 11, 2011 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Endotoxin Activity [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ] Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest). |
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| Original Primary Outcome Measures ICMJE |
Endotoxin levels and activity [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00772772 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vitamin D Repletion in Chronic Kidney Disease | ||||
| Official Title ICMJE | The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3 | ||||
| Brief Summary | The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called "endotoxin". The blood levels of this substance are high in people with medium-level kidney disease. We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal subjects are enrolled to have a 'control' set for comparison purposes. |
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| Detailed Description | Your participation in this study requires:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Kidney Disease | ||||
| Intervention ICMJE | Drug: Vitamin D3
2 single oral dose of Vitamin D3 30,000 international units and 8 weeks supply of Vitamin D3 (10,000 IU tablets, 3 pills to be taken by mouth as one dose weekly) |
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| Study Arm (s) | Experimental: Vitamin D3
Vitamin D3 30,000 international units orally per week for 8 weeks
Intervention: Drug: Vitamin D3 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 12 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion Criteria for Healthy volunteers (Currently Recruiting)
Inclusion Criteria for Medium-level Kidney Function volunteers (Closed to Recruitment)
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00772772 | ||||
| Other Study ID Numbers ICMJE | MAP-0626 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Manish Ponda, MD, Rockefeller University | ||||
| Study Sponsor ICMJE | Rockefeller University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rockefeller University | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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