Vitamin D and Arteriovenous Fistulae

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Monnie Wasse MD, MPH, FASN, Emory University
ClinicalTrials.gov Identifier:
NCT00912782
First received: June 1, 2009
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
End-stage Renal Disease
Drug: Vitamin D3
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Arteriovenous Fistulae Maturation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 25-hydroxyvitamin D and Serum Calcium [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo one time per week for 3 weeks
Drug: Placebo
Placebo one time per week for 3 weeks
Other Name: Placebo
Experimental: Cholecalciferol
Vitamin D 200,000 IU per week for 3 weeks
Drug: Vitamin D3
Vitamin D3 200,000 IU once a week for 3 weeks
Other Name: Vitamin D3

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912782

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Haimanot Wasse, MD, MPH Emory University
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Monnie Wasse MD, MPH, FASN, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00912782     History of Changes
Other Study ID Numbers: IRB00014859
Study First Received: June 1, 2009
Results First Received: November 2, 2013
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
ESRD
Vitamin D
Arteriovenous Fistulae
Dialysis Vascular Access

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Kidney Diseases
Kidney Failure, Chronic
Arteriovenous Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Vascular Diseases
Vascular Fistula
Vascular Malformations
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014