Trial Outcomes & Findings for Supplementation With Cholecalciferol in Dialysis Patients (NCT NCT01974245)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-03-14

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Placebo 100 drops placebo solution/week	Cholecalciferol Cholecalciferol: 100,000 IU/week
Overall Study STARTED	27	28
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supplementation With Cholecalciferol in Dialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=18 Participants 100 drops/week	Cholecalciferol n=20 Participants Cholecalciferol: 100,000 IU/week	Total n=38 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 12.9 • n=5 Participants	55.5 years STANDARD_DEVIATION 14.2 • n=7 Participants	56.0 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Brazil	18 participants n=5 Participants	20 participants n=7 Participants	38 participants n=5 Participants
Dialysis therapy Peritoneal dialysis	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Dialysis therapy Hemodialysis	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants 100 drops/week for 12 weeks	Cholecalciferol n=20 Participants Cholecalciferol: 100,000 IU/week for 12 weeks
Change From Baseline in Interleukin-6 at 12 Weeks. Interleukin-6 baseline	9.0 pg/mL Standard Deviation 5.2	8.1 pg/mL Standard Deviation 6.6
Change From Baseline in Interleukin-6 at 12 Weeks. Interleukin-6 after intervention	9.6 pg/mL Standard Deviation 5.6	4.6 pg/mL Standard Deviation 4.1

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cholecalciferol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lilian Cuppari

Federal University of São Paulo

Phone: +551159048499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place