Trial Outcomes & Findings for Vitamin D and Arteriovenous Fistulae (NCT NCT00912782)

NCT ID: NCT00912782

Last Updated: 2014-07-02

Results Overview

Maturation of an AVF is the ability to stick the AVF with two large bore needles at ≥ 6 consecutive dialysis sessions, and achievement of an AVF blood flow \>300 ml/min, assessed at six months following AVF creation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-07-02

Participant Flow

107 Assessed for Eligibility with 55 Excluded for declining to participate (12), not meeting criteria (41), and other reasons (6) leaving 52 patients randomly assigned for the study. Some individuals were counted as having more than two reasons to be excluded from the study.

Participant milestones

Measure	Placebo Placebo one time per week for 3 weeks	Cholecalciferol Vitamin D 200,000 IU per week for 3 weeks
Overall Study STARTED	27	25
Overall Study COMPLETED	24	20
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Placebo Placebo one time per week for 3 weeks	Cholecalciferol Vitamin D 200,000 IU per week for 3 weeks
Overall Study Death	2	1
Overall Study Lost to Follow-up	0	1
Overall Study Did not receive vascular access type	1	2
Overall Study Relocated before study completion	0	1

Baseline Characteristics

Vitamin D and Arteriovenous Fistulae

Baseline characteristics by cohort

Measure	Placebo n=27 Participants Placebo one time per week for 3 weeks	Cholecalciferol n=25 Participants Vitamin D 200,000 IU per week for 3 weeks	Total n=52 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 14.9 • n=5 Participants	49.9 years STANDARD_DEVIATION 10.9 • n=7 Participants	51.1 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	25 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Maturation of an AVF is the ability to stick the AVF with two large bore needles at ≥ 6 consecutive dialysis sessions, and achievement of an AVF blood flow >300 ml/min, assessed at six months following AVF creation.

Outcome measures

Measure	Placebo n=24 Participants Placebo one time per week for 3 weeks	Cholecalciferol n=20 Participants Vitamin D 200,000 IU per week for 3 weeks
Arteriovenous Fistulae Maturation	50 percentage of group	40 percentage of group

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Measure	Placebo n=24 Participants Placebo one time per week for 3 weeks	Cholecalciferol n=20 Participants Vitamin D 200,000 IU per week for 3 weeks
25-hydroxyvitamin D and Serum Calcium Serum 25 (OH) D	18.4 ng/mL Standard Deviation 7.4	53.4 ng/mL Standard Deviation 17.7
25-hydroxyvitamin D and Serum Calcium Serum Calcium	9.1 ng/mL Standard Deviation 0.6	8.8 ng/mL Standard Deviation 0.9

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

Monnie Wasse MD/MPH / Associate Professor of Medicine

Emory University

Phone: 404-727-1598

Email: hwasse@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place