Chronic Kidney Disease
Conditions
Keywords
Cholecalciferol, Kidney diseases
Brief summary
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.
Interventions
DRUGCholecalciferol
100,000 IU/week for 12 weeks
DRUGPlacebo
100 drops/ week for 12 weeks
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 25 (OH) \< 20 ng/ml * Peritoneal dialysis or hemodialysis \> 3 months
Exclusion criteria
* Use of vitamin D or its analogues, corticosteroids and immunosuppressive * Peritonitis in the previous month at baseline * Liver, neoplastic, infectious or autoimmune diseases and positive HIV * Hypercalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Interleukin-6 at 12 Weeks. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in C-reactive Protein at 12 Weeks | 12 weeks |
Other
| Measure | 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 |
Countries
Brazil
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 100 drops/week | 18 |
| Cholecalciferol Cholecalciferol: 100,000 IU/week | 20 |
| Total | 38 |
Baseline characteristics
| Characteristic | Placebo | Cholecalciferol | Total |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 12.9 | 55.5 years STANDARD_DEVIATION 14.2 | 56.0 years STANDARD_DEVIATION 13.4 |
| Dialysis therapy Hemodialysis | 12 participants | 11 participants | 23 participants |
| Dialysis therapy Peritoneal dialysis | 6 participants | 9 participants | 15 participants |
| Region of Enrollment Brazil | 18 participants | 20 participants | 38 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 |
Outcome results
Primary
Change From Baseline in Interleukin-6 at 12 Weeks.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Interleukin-6 at 12 Weeks. | Interleukin-6 baseline | 9.0 pg/mL | Standard Deviation 5.2 |
| Placebo | Change From Baseline in Interleukin-6 at 12 Weeks. | Interleukin-6 after intervention | 9.6 pg/mL | Standard Deviation 5.6 |
| Cholecalciferol | Change From Baseline in Interleukin-6 at 12 Weeks. | Interleukin-6 baseline | 8.1 pg/mL | Standard Deviation 6.6 |
| Cholecalciferol | Change From Baseline in Interleukin-6 at 12 Weeks. | Interleukin-6 after intervention | 4.6 pg/mL | Standard Deviation 4.1 |
Secondary
Change From Baseline in C-reactive Protein at 12 Weeks
Time frame: 12 weeks
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
Time frame: 12 weeks