Vitamin D and Arteriovenous Fistulae
Completed · Not applicable · Has a placebo group
Conditions studied: End-stage Renal Disease
In brief
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.
Key facts
- Study ID
- NCT00912782
- Run by
- Emory University
- People needed
- 52
- Starts
- 2009-01-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2014-07-02
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with patients with end-stage renal disease (ESRD) who are suitable candidates for AVF creation (as assessed by pre-operative vein mapping) and plan to undergo AVF creation are eligible to participate
- Study subjects must agree to participate in the study and provide written informed consent
- Age: Study subjects must be > 18 years old
- Sites: Emory University affiliated hospitals (including Emory University Hospital, Emory Midtown Hospital, Grady Memorial Hospital) and Emory University affiliated outpatient dialysis units
- Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent.
You may not qualify if…
- Age < 18 years
- Patients with a corrected serum calcium > 10.5 mg/dL within 4 weeks of study screening
- Current intake of > 2000 IU per day of Vitamin D3
- Subjects unable to provide informed consent or who plan to relocate outside of Atlanta during the study duration
Where it is running
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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