A Phase 2 interventional study of Cholecalciferol and Placebo in Chronic Kidney Disease, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Federal University of São Paulo · Phase 2, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 55 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100 drops/week for 12 weeks
Drug: Placebo
Drug: Cholecalciferol - 100,000 IU/week
Drug: Cholecalciferol
100,000 IU/week for 12 weeks
Also known as: Vitamina D3
100 drops/ week for 12 weeks
Change From Baseline in Interleukin-6 at 12 Weeks.
Time frame: 12 weeks
Change From Baseline in C-reactive Protein at 12 Weeks
Time frame: 12 weeks
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
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.
| Milestone | Placebo | Cholecalciferol |
|---|---|---|
| Started | 27 | 28 |
| Completed | 18 | 20 |
| Not completed | 9 | 8 |
| pg/mL | Placebo | Cholecalciferol |
|---|---|---|
| Interleukin-6 baseline | 9.0 ± 5.2 | 8.1 ± 6.6 |
| Interleukin-6 after intervention | 9.6 ± 5.6 | 4.6 ± 4.1 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/18 (0%) | 0/18 (0%) |
| Cholecalciferol | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Placebo | Cholecalciferol | Total |
|---|---|---|---|
| Mean | 56.5 ± 12.9 | 55.5 ± 14.2 | 56.0 ± 13.4 |
| Sex: Female, Male(Participants) | Placebo | Cholecalciferol | Total |
|---|---|---|---|
| Female | 9 | 9 | 18 |
| Male | 9 | 11 | 20 |
| Region of Enrollment(participants) | Placebo | Cholecalciferol | Total |
|---|---|---|---|
| Brazil | 18 | 20 | 38 |
| Dialysis therapy(participants) | Placebo | Cholecalciferol | Total |
|---|---|---|---|
| Peritoneal dialysis | 6 | 9 | 15 |
| Hemodialysis | 12 | 11 | 23 |
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo