Trial Outcomes & Findings for Impact of Vitamin D Repletion in Hemodialysis Patients (NCT NCT01175798)

Results Overview

Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

116 participants

Primary outcome timeframe

1 year

Results posted on

2014-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	No Treatment (Standard of Care) Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).	Vitamin D Repletion Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion). Cholecalciferol: 50,000 IU PO weekly x 6 weeks
Overall Study STARTED	34	62
Overall Study COMPLETED	27	41
Overall Study NOT COMPLETED	7	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Vitamin D Repletion in Hemodialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Treatment (Standard of Care) n=34 Participants Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).	Vitamin D Repletion n=62 Participants Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion). Cholecalciferol: 50,000 IU PO weekly x 6 weeks	Total n=96 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 14.9 • n=93 Participants	60.2 years STANDARD_DEVIATION 14.3 • n=4 Participants	59 years STANDARD_DEVIATION 15 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	26 Participants n=4 Participants	40 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	36 Participants n=4 Participants	56 Participants n=27 Participants
25(OH) vitamin D	13.1 ng/dL n=93 Participants	13.4 ng/dL n=4 Participants	13.2 ng/dL n=27 Participants

PRIMARY outcome

Timeframe: 1 year

Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months.

Outcome measures

Outcome measures
Measure	No Treatment (Standard of Care) n=27 Participants Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).	Vitamin D Repletion n=41 Participants Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion). Cholecalciferol: 50,000 IU PO weekly x 6 weeks
Change in 25OH-Vitamin D Level	15.8 ng/dL Interval 9.5 to 19.5	40.9 ng/dL Interval 32.2 to 45.5

SECONDARY outcome

Timeframe: 1 year

Secondary outcomes to be measured include change in peripheral blood mononuclear cell (PBMC) profile by flow cytometry at 6 and 12 months, change in ELISPOT-based panel of reactive T cell (PRT) readout at 6 and 12 months, change in PMBC cytokine production in response to toll-like-receptor stimulation at 6 and 12 months, and response to influenza vaccination.

Outcome measures

Outcome data not reported

Adverse Events

No Treatment (Standard of Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D Repletion

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

Anita Mehrotra MD

Icahn School of Medicine at Mount Sinai

Phone: 2122415153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place