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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK078774 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.
This RCT will enroll 74 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.
There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.
Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D 50000 IU | Experimental | Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. |
|
| Placebo | Placebo Comparator | Patients randomized to this arm will receive a placebo pill once weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures. | Urine albumin and creatinine were measured on spot urine specimens. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome. | 25(OH) vitamin D levels were measured using liquid chromatography. | 3 months |
| Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Melamed, MD, MHS | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore medical center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D 50000 IU | Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months |
| FG001 | Placebo | Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D 50000 IU | Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months |
| BG001 | Placebo |
| 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 | Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures. | Urine albumin and creatinine were measured on spot urine specimens. | Posted | Mean | Standard Deviation | mg/gram creatinine | 3 months |
|
12 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 D 50000 IU | Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Hospitalization and ED Visits | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michal Melamed | Albert Einstein College of Medicine | 718-430-2304 | michal.melamed@einsteinmed.edu |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo | Other | Patients randomized to this arm will receive one placebo pill once weekly. |
|
| 3 months |
Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome. | 25(OH) vitamin D levels were measured using liquid chromatography. | Posted | Mean | Standard Deviation | ng/mL | 3 months |
|
|
|
| Secondary | Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome. | Ambulatory pressure data readings were not collected and therefore data was not able to be aggregated and analyzed. | Posted | 3 months |
|
|
| 0 |
| 36 |
| 12 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo | Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly. | 0 | 38 | 17 | 38 | 0 | 38 |
| Non-cardiac Hospitalization and ED Visits | General disorders | Systematic Assessment |
|
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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 |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |