CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Vitamin D3 +1 moredrug
Likely dose
Vitamin D3 200,000 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00912782
NCT00912782N/ACompleted

Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients

Emory University·interventional·Posted Jun 3, 2009·Updated Jul 2, 2014

In Brief

A clinical study evaluating Vitamin D3 and Placebo for End-stage Renal Disease. Completed, enrolled 52 participants across 1 site.

Detailed Summary

Patients requiring hemodialysis following kidney failure need a form of dialysis vascular access in order to undergo the dialysis procedure. Dialysis vascular access dysfunction is an enormous clinical problem. While the best form of vascular access is the arteriovenous fistula (AVF), its primary problem is early, aggressive cellular ingrowth that leads to poor maturation of the vessel, preventing its use for dialysis. Strategies to prevent AVF failure are needed. Vitamin D is a hormone present in all human bodies and is important for good bone formation and immune function. There is new information that links vitamin D to the function of our veins and arteries, which are used in the creation of an arteriovenous fistulae. Our bodies can make vitamin D and can also get vitamin D from our diet. However, a majority of patients with chronic kidney disease and end-stage renal disease (ESRD) have low vitamin D levels (vitamin D deficiency). There are several benefits to correcting low vitamin D levels, however, it is not know whether correcting low vitamin D in the body will lead to better function of the vein and artery used for arteriovenous fistulae creation. The main goal of this pilot study is to examine the role of vitamin D supplementation on AVF maturation and useability for dialysis. Study results will be used to develop larger studies to examine the specific effect that vitamin D supplementation has on the vessels used for AVF creation and whether vitamin D promotes AVF maturation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2009
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.1 years ago

Interventions

Vitamin D3drug

Vitamin D3 200,000 IU once a week for 3 weeks

Placebodrug

Placebo one time per week for 3 weeks