Vitamin D and Arteriovenous Fistulae

NCT ID: NCT00912782

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-06-30

Brief 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.

Detailed Description

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.

Conditions

End-stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo one time per week for 3 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo one time per week for 3 weeks

Cholecalciferol

Vitamin D 200,000 IU per week for 3 weeks

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

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

Interventions

Vitamin D3

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

Intervention Type: DRUG

Placebo

Placebo one time per week for 3 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Monnie Wasse MD, MPH, FASN

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haimanot Wasse, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

References

Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.

Reference Type: DERIVED

PMID: 34298589 (View on PubMed)

Wasse H, Huang R, Long Q, Zhao Y, Singapuri S, McKinnon W, Skardasis G, Tangpricha V. Very high-dose cholecalciferol and arteriovenous fistula maturation in ESRD: a randomized, double-blind, placebo-controlled pilot study. J Vasc Access. 2014 Mar-Apr;15(2):88-94. doi: 10.5301/jva.5000187. Epub 2013 Oct 7.

Reference Type: DERIVED

PMID: 24101420 (View on PubMed)

Wasse H, Huang R, Long Q, Singapuri S, Raggi P, Tangpricha V. Efficacy and safety of a short course of very-high-dose cholecalciferol in hemodialysis. Am J Clin Nutr. 2012 Feb;95(2):522-8. doi: 10.3945/ajcn.111.025502. Epub 2012 Jan 11.

Reference Type: DERIVED

PMID: 22237061 (View on PubMed)

Other Identifiers

IRB00014859

Identifier Type: -

Identifier Source: org_study_id