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Vitamin D deficiency accelerates vascular risk progression after kidney transplant.
This trial will assess the following aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard vitamin treatment | Other | 10,000 I.U. of vitamin D3 weekly |
|
| 50,000 I.U. of vitamin D3 | Active Comparator | 50,000 I.U. of vitamin D3 weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard vitamin D3 treatment | Dietary Supplement | 10,000 I.U./wk of vitamin D3 orally for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations. | The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration. | The 6 month change (6 month - Baseline) in parathyroid hormone concentration was compared between the two treatment arms. | baseline and 6 months |
| The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Larsen, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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165 subjects were screened, and 93 subjects were eligible and were randomized to treatments. Three patients voluntarily withdrew consent immediately following randomization. A total of 90 subjects received treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Vitamin Treatment | Standard vitamin treatment vitamin D3: Participants receive 10,000 I.U./wk of vitamin D3 orally for 6 months |
| FG001 | 50,000 I.U. of Vitamin D3 | 50,000 I.U. of vitamin D3 vitamin D3: Participants receive 50,000 I.U./wk of vitamin D3 orally for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Vitamin Treatment | Standard vitamin treatment vitamin D3: 10,000 I.U./wk of vitamin D3 orally for 6 months |
| BG001 | 50,000 I.U. of Vitamin D3 | 50,000 I.U. of vitamin D3 vitamin D3: 50,000 I.U./wk of vitamin D3 orally for 6 months |
| 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 | Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations. | The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels. | Patients who had baseline and 6 month 25-hydroxy Vitamin D levels measured | Posted | Median | Full Range | ng/ml | Baseline and 6 months |
|
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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 | Standard Vitamin Treatment | Standard vitamin treatment vitamin D3: Participants receive 10,000 I.U./wk of vitamin D3 orally for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated calcium | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fang Yu | University of Nebraska Medical Center | (402) 559-9436 | fangyu@unmc.edu |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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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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| High dose vitamin D3 treatment | Dietary Supplement | 50,000 I.U./wk of vitamin D3 orally for 6 months |
|
|
The 6 month change (6 month - Baseline) in spot urine protein-creatinine ratio was compared between the two treatment arms. |
| 6 months |
| The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels. | The 6 month change in High-sensitivity C-reactive protein (HsCRP) levels was compared between the two treatment arms. | Baseline and 6 months |
| The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months | The 6 month change (6 month - Baseline) in insulin resistance was assessed with HOMA-IR (Homeostatic Model Assessment-Insulin Resistance), which is calculated by fasting glucose (mg/dL) X fasting insulin (mU/L) /405. | Baseline and 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Vitamin D Concentration | Mean | Standard Deviation | ng/ml |
|
|
|
| Secondary | The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration. | The 6 month change (6 month - Baseline) in parathyroid hormone concentration was compared between the two treatment arms. | Available data from patients who had baseline and 6 month parathyroid hormone concentration levels obtained. | Posted | Median | Full Range | pg/ml | baseline and 6 months |
|
|
|
| Secondary | The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio. | The 6 month change (6 month - Baseline) in spot urine protein-creatinine ratio was compared between the two treatment arms. | Available data from patients who had baseline and 6 month spot urine protein-creatinine ratio levels obtained. | Posted | Median | Full Range | mg/mmol | 6 months |
|
|
|
| Secondary | The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels. | The 6 month change in High-sensitivity C-reactive protein (HsCRP) levels was compared between the two treatment arms. | Available data from patients who had baseline and 6 month HsCRP levels obtained | Posted | Median | Full Range | mg/dl | Baseline and 6 months |
|
|
|
| Secondary | The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months | The 6 month change (6 month - Baseline) in insulin resistance was assessed with HOMA-IR (Homeostatic Model Assessment-Insulin Resistance), which is calculated by fasting glucose (mg/dL) X fasting insulin (mU/L) /405. | Available data from patients who had baseline and 6 month HOMA-IR levels obtained. | Posted | Median | Full Range | (microU/L) x (nmol/L) | Baseline and 6 months |
|
|
|
| 0 |
| 46 |
| 1 |
| 46 |
| EG001 | 50,000 I.U. of Vitamin D3 | 50,000 I.U. of vitamin D3 vitamin D3: Participants receive 50,000 I.U./wk of vitamin D3 orally for 6 months | 1 | 44 | 2 | 44 |
| Reoccurring UTI | Renal and urinary disorders | Non-systematic Assessment |
|
| Enteric Conversion | Renal and urinary disorders | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |