End-stage Renal Disease Clinical Trial
Official title:
Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients
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.
Hemodialysis vascular access dysfunction is a major source of morbidity and cost among ESRD
patients, accounting for up to 25% of all hospital stays, and 50% of all costs within the
first year of initiating dialysis.The AVF provides higher blood flow rates, fewer thrombotic
and infectious complications, and lower morbidity and cost compared with prosthetic grafts
or central venous catheters.However,up to 50% of newly created AVF's fail to mature
sufficiently for chronic hemodialysis use. Clearly, determining factors predictive of poor
AVF maturation are important from both patient care and health policy perspectives and are
worthy of investigation.
Vitamin D has antiproliferative, antioxidant and antiangiogenic properties. The observed
association of vitamin D deficiency and increased risk of cardiovascular and peripheral
vascular disease may extend to the vasculature used in the creation of an AVF.
As renal function worsens, patients with chronic kidney disease (CKD) produce less vitamin
D, due to impaired renal conversion of 25-hydroxy- to 1,25-dihydroxyvitamin D by declining
renal 1-alpha hydroxylase. As a result, at the time of dialysis initiation,78%-90% of ESRD
patients are vitamin D deficient. Until recently, vitamin D deficiency among CKD and ESRD
patients was only treated if hyperparathyroidism was present, however, more attention is now
paid to nutritional vitamin D deficiency given its association with a range of comorbid
conditions.Furthermore, 1,25-dihydroxyvitamin D and its analogue compounds are associated
with improved survival in the CKD and ESRD populations. We believe that the observed
benefits of vitamin D may improve AVF maturation among a population in which vitamin D
deficiency is highly prevalent.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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