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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially in those undergoing dialysis. The loss of protein to the dialysis solution seems to contribute significantly to the reduced serum levels of vitamin D in these patients. As a result of the disease and the dialysis procedure, there is high prevalence of chronic inflammation and high risk of infections. There is evidence in other populations, that vitamin D has immunomodulatory effects by stimulating the production of cathelicidin, an antimicrobial peptide and suppressing the production of proinflammatory cytokines. Thus, this study aims to investigate the effects of cholecalciferol supplementation on immunological markers in patients in hemodialysis and peritoneal dialysis with hypovitaminosis D . This is a randomized, double-blind, placebo-controlled trial in which patients who have vitamin D deficiency [25 (OH) D <20 ng / mL] will be allocated to the intervention group (cholecalciferol) or control (placebo). Patients will receive supplemented 100,000 IU / week cholecalciferol a period of 12 weeks. Before and after the intervention will be determined 25(OH)D, cathelicidin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive protein serum. In monocytes, we will evaluate cathelicidin, IL-6 and TNF-α, 25(OH)D receptor and α 1-hydroxylase enzyme expression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 100 drops/week for 12 weeks |
|
| Cholecalciferol | Active Comparator | Drug: Cholecalciferol - 100,000 IU/week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | 100,000 IU/week for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Interleukin-6 at 12 Weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in C-reactive Protein at 12 Weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilian Cuppari, PhD | Federal University of São Paulo | Principal Investigator |
| Marion S Meireles, Master | Federal University of São Paulo | Principal Investigator |
| Maria A Kamimura, PhD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo | São Paulo | 04039-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27161894 | Derived | Meireles MS, Kamimura MA, Dalboni MA, Giffoni de Carvalho JT, Aoike DT, Cuppari L. Effect of cholecalciferol on vitamin D-regulatory proteins in monocytes and on inflammatory markers in dialysis patients: A randomized controlled trial. Clin Nutr. 2016 Dec;35(6):1251-1258. doi: 10.1016/j.clnu.2016.04.014. Epub 2016 Apr 26. |
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Patients that have in use of any vitamin D compounds, glucocorticoids, immunosuppressors, or with history of liver failure, intestinal malabsorption, malignance, autoimmune disease, active infection, positive HIV, peritonitis in the last month or elevated serum ionized calcium (>1.40 mmol/L) were not included in the study.
Between September 2012 and May 2014 the patients from Dialysis Unit of the Federal University of São Paulo and Oswaldo Ramos Foundation (São Paulo, Brazil) were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 100 drops placebo solution/week |
| FG001 | Cholecalciferol | Cholecalciferol: 100,000 IU/week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 100 drops/week |
| BG001 | Cholecalciferol | Cholecalciferol: 100,000 IU/week |
| 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 From Baseline in Interleukin-6 at 12 Weeks. | Posted | Mean | Standard Deviation | pg/mL | 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 | Placebo | 100 drops/week for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lilian Cuppari | Federal University of São Paulo | +551159048499 | lcuppari@uol.com.br |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | 100 drops/ week for 12 weeks |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dialysis therapy | Number | participants |
|
|
| Secondary | Change From Baseline in C-reactive Protein at 12 Weeks | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks | Not Posted | 12 weeks | Participants |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Cholecalciferol | Cholecalciferol: 100,000 IU/week for 12 weeks | 0 | 20 | 0 | 20 |
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| 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 |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |