Trial Outcomes & Findings for Vitamin D Repletion in Chronic Kidney Disease (NCT NCT00772772)

Results Overview

Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

12 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2015-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin D3 Vitamin D3 30,000 units PO weekly for 8 weeks
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Repletion in Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 n=12 Participants
Age, Continuous	61 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: Per protocol. Result is expressed as change in endotoxin activity with therapy

Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).