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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.
Your participation in this study requires:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | Vitamin D3 30,000 international units orally per week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endotoxin Activity | 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). | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | after 8 weeks of vitamin D therapy | |
| Intestinal Permeability | after 8 weeks of vitamin D therapy | |
| Nuclear Magnetic Resonance (NMR) Lipoprotein Profile |
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Inclusion Criteria:
Inclusion Criteria for Healthy volunteers
Inclusion Criteria for Medium-level Kidney Function volunteers
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manish Ponda, MD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D3 | Vitamin D3 30,000 units PO weekly for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Endotoxin Activity | 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). | Per protocol. Result is expressed as change in endotoxin activity with therapy | Posted | Mean | Standard Deviation | EA units | baseline and 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metabolic | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mansih Ponda | The Rockefeller University | 212-327-7631 | mponda@rockefeller.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| after 8 weeks of vitamin D therapy |
| 25-hydroxy Vitamin D (25-OH Vitamin D) | 25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly. | after 8 weeks of vitamin D therapy |
| 1, 25-OH Vitamin D | after 8 weeks of vitamin D therapy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Blood Pressure | Not Posted | after 8 weeks of vitamin D therapy |
| Secondary | Intestinal Permeability | Not Posted | after 8 weeks of vitamin D therapy |
| Secondary | Nuclear Magnetic Resonance (NMR) Lipoprotein Profile | Not Posted | after 8 weeks of vitamin D therapy |
| Secondary | 25-hydroxy Vitamin D (25-OH Vitamin D) | 25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly. | Patients with chronic kidney disease had 25-OH vitamin D levels measured at baseline and after 8 weeks of Vitamin D3 therapy. Analysis was per protocol. | Posted | Mean | Standard Error | ng/ml | after 8 weeks of vitamin D therapy |
|
|
|
| Secondary | 1, 25-OH Vitamin D | Not Posted | after 8 weeks of vitamin D therapy |
| 0 |
| 12 |
| 4 |
| 12 |
| Cardiovascular | Cardiac disorders |
|
| Hematologic | Blood and lymphatic system disorders |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |