End-stage Renal DiseaseNCT00912782
Vitamin D and Arteriovenous Fistulae
A study testing Vitamin D3 in people with End-stage Renal Disease, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients
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.
Read the 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
- Being tested
- Vitamin D3, Placebo
- Keywords
- ESRD, Vitamin D, Arteriovenous Fistulae, Dialysis Vascular Access
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Vitamin D3 200,000 IU once a week for 3 weeks
PlaceboDrug
Placebo one time per week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo one time per week for 3 weeks Receives: Drug: Placebo |
| Cholecalciferol | Experimental | Vitamin D 200,000 IU per week for 3 weeks Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
25-hydroxyvitamin D and Serum Calcium
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monnie Wasse MD, MPH, FASN, Emory University
- Investigators
- Haimanot Wasse, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912782
- Sponsor's protocol ID
- IRB00014859
- Status last verified
- Jun 2014
- First submitted
- 1 Jun 2009
- Last updated
- 2 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34298589Wasse 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.
PubMed 24101420Wasse 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.
PubMed 22237061
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D on Arteriovenous Fistulae Maturation Among ESRD Patients
- ClinicalTrials.gov ID
- NCT00912782
- Acronym / sponsor ID
- IRB00014859
- Conditions
- End-stage Renal Disease
- Keywords
- ESRD, Vitamin D, Arteriovenous Fistulae, Dialysis Vascular Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 2 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo one time per week for 3 weeks |
| Cholecalciferol | Experimental | Drug: Vitamin D3Vitamin D 200,000 IU per week for 3 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Vitamin D3 200,000 IU once a week for 3 weeks | Drug | Cholecalciferol |
| PlaceboPlacebo one time per week for 3 weeks | Drug | Placebo |
Primary outcome
Arteriovenous Fistulae Maturation
Time frame: 6 months
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.
1 secondary outcome
25-hydroxyvitamin D and Serum Calcium
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34298589Mohamed 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.
- Derived from this study: PubMed 24101420Wasse 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.
- Derived from this study: PubMed 22237061Wasse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haimanot Wasse, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with End-stage Renal Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arteriovenous Fistulae Maturation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00912782, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.