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Vitamin D and Arteriovenous Fistulae

Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00912782
Enrollment
52
Registered
2009-06-03
Start date
2009-01-31
Completion date
2011-06-30
Last updated
2014-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease

Keywords

ESRD, Vitamin D, Arteriovenous Fistulae, Dialysis Vascular Access

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.

Interventions

DRUGVitamin D3

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

DRUGPlacebo

Placebo one time per week for 3 weeks

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Arteriovenous Fistulae Maturation6 monthsMaturation 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

MeasureTime frame
25-hydroxyvitamin D and Serum Calcium10 weeks

Countries

United States

Participant flow

Pre-assignment details

107 Assessed for Eligibility with 55 Excluded for declining to participate (12), not meeting criteria (41), and other reasons (6) leaving 52 patients randomly assigned for the study. Some individuals were counted as having more than two reasons to be excluded from the study.

Participants by arm

ArmCount
Placebo
Placebo one time per week for 3 weeks
27
Cholecalciferol
Vitamin D 200,000 IU per week for 3 weeks
25
Total52

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath21
Overall StudyDid not receive vascular access type12
Overall StudyLost to Follow-up01
Overall StudyRelocated before study completion01

Baseline characteristics

CharacteristicPlaceboTotalCholecalciferol
Age, Continuous52.1 years
STANDARD_DEVIATION 14.9
51.1 years
STANDARD_DEVIATION 13.2
49.9 years
STANDARD_DEVIATION 10.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
21 Participants40 Participants19 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants12 Participants6 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
27 participants52 participants25 participants
Sex: Female, Male
Female
9 Participants14 Participants5 Participants
Sex: Female, Male
Male
18 Participants38 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 270 / 25
serious
Total, serious adverse events
0 / 270 / 25

Outcome results

Primary

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.

Time frame: 6 months

ArmMeasureValue (NUMBER)
PlaceboArteriovenous Fistulae Maturation50 percentage of group
CholecalciferolArteriovenous Fistulae Maturation40 percentage of group
Secondary

25-hydroxyvitamin D and Serum Calcium

Time frame: 10 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Placebo25-hydroxyvitamin D and Serum CalciumSerum Calcium9.1 ng/mLStandard Deviation 0.6
Placebo25-hydroxyvitamin D and Serum CalciumSerum 25 (OH) D18.4 ng/mLStandard Deviation 7.4
Cholecalciferol25-hydroxyvitamin D and Serum CalciumSerum Calcium8.8 ng/mLStandard Deviation 0.9
Cholecalciferol25-hydroxyvitamin D and Serum CalciumSerum 25 (OH) D53.4 ng/mLStandard Deviation 17.7

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026