Vitamin D and Arteriovenous Fistulae

NCT00912782 | Completed Results

• 1 other identifier: IRB00014859
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Keywords

ESRD; Vitamin D; Arteriovenous Fistulae; Dialysis Vascular Access

Outcome Measures

Primary Outcomes (1)

• Arteriovenous Fistulae Maturation

  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.

  6 months

Secondary Outcomes (1)

• 25-hydroxyvitamin D and Serum Calcium

  10 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo one time per week for 3 weeks

Drug: Placebo

Cholecalciferol

EXPERIMENTAL

Vitamin D 200,000 IU per week for 3 weeks

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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

Cholecalciferol

Placebo DRUG

Placebo one time per week for 3 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (3)

• 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.

  PMID: 34298589 DERIVED

• 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.

  PMID: 24101420 DERIVED

• 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.

  PMID: 22237061 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Monnie Wasse MD/MPH / Associate Professor of Medicine
• Organization: Emory University

hwasse@emory.edu

404-727-1598

Study Officials

• Haimanot Wasse, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 2, 2014
• Results First Posted: July 2, 2014

Record last verified: 2014-06

Locations

US (1)