End-Stage Renal DiseaseNCT00677534
Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
A study testing Cholecalciferol in people with End-Stage Renal Disease, run by University of Kansas.
Trial summary
The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease Read more about this study
- Who is it for?
- Ages 21 to 88 years
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Aug 2009
- 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 21 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage renal disease undergoing maintenance hemodialysis at KUMC outpatient hemodialysis unit
- Dialysis vintage of at least 6 months duration
- Nutritional vitamin D deficiency, defined as 25(OH)D <25 ng/ml
- Age 21 to 88 years
Who cannot join
- Active infection
- Recent hospitalization for acute illness (within last 1 month)
- Refusal to study participation
- Poorly controlled secondary hyperparathyroidism (iPTH>500)
- History of chronic inflammatory disease process, such as inflammatory bowel, rheumatoid arthritis, lupus, etc.
- Cinacalcet therapy
Show all 11Show fewer
- Previous allergy to ergocalciferol
- History of parathyroidectomy
- Current treatment with immunosuppressant medications
- Noncompliance with prescribed hemodialysis regimen (i.e. skipping treatments, ending sessions early)
- Functional renal transplant within the last five years
About this study
Official title: Exploring the Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease
Read the detailed description
The goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase activity in the setting of renal failure and to evaluate the role of nutritional vitamin D deficiency as a potential contributor to monocyte-associated inflammatory pathways in patients with end-stage renal disease (ESRD). This study will consist of patients on chronic maintenance hemodialysis three times per week who have been identified to have nutritional vitamin D deficiency. After consent for study enrollment, patients will undergo a 4 week washout period of all active vitamin D supplementation. After washout is complete, an blood sample will be obtained for baseline 25(OH)D levels and monocyte isolation for analysis by flow cytometry. Patients will then be started on cholecalciferol 50,000 IU twice weekly for 8 weeks. 25-vitamin D levels will be monitored midway through the treatment phase of the study and dosing adjusted as further described in detail within the protocol section. An additional blood sample will be drawn post-therapy for repeat 25(OH)D levels and monocyte isolation for flow cytometry analysis.
- Conditions
- End-Stage Renal Disease
- Being tested
- Cholecalciferol
- Keywords
- Endstage renal disease, Vitamin D, Monocyte function
- 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.
CholecalciferolDrug
Also called Vitamin D, ergocalciferol
50,000 Units PO Twice weekly for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cholecalciferol (Vitamin D) Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monocyte VDR Expression With Vitamin D Therapy
Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.
Measured: Change from End of Washout to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2009
- Study completionAug 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Stubbs, MD, University of Kansas
- Investigators
- Jason Stubbs, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677534
- Sponsor's protocol ID
- 11225
- Status last verified
- Apr 2014
- First submitted
- 12 May 2008
- Last updated
- 29 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stubbs JR, Idiculla A, Slusser J, Menard R, Quarles LD. Cholecalciferol supplementation alters calcitriol-responsive monocyte proteins and decreases inflammatory cytokines in ESRD. J Am Soc Nephrol. 2010 Feb;21(2):353-61. doi: 10.1681/ASN.2009040451. Epub 2009 Dec 10.
PubMed 20007751
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00677534
- Acronym / sponsor ID
- 11225
- Conditions
- End-Stage Renal Disease
- Keywords
- Endstage renal disease, Vitamin D, Monocyte function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Posted 21 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease
Detailed description
The goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase activity in the setting of renal failure and to evaluate the role of nutritional vitamin D deficiency as a potential contributor to monocyte-associated inflammatory pathways in patients with end-stage renal disease (ESRD). This study will consist of patients on chronic maintenance hemodialysis three times per week who have been identified to have nutritional vitamin D deficiency. After consent for study enrollment, patients will undergo a 4 week washout period of all active vitamin D supplementation. After washout is complete, an blood sample will be obtained for baseline 25(OH)D levels and monocyte isolation for analysis by flow cytometry. Patients will then be started on cholecalciferol 50,000 IU twice weekly for 8 weeks. 25-vitamin D levels will be monitored midway through the treatment phase of the study and dosing adjusted as further described in detail within the protocol section. An additional blood sample will be drawn post-therapy for repeat 25(OH)D levels and monocyte isolation for flow cytometry analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CholecalciferolCholecalciferol (Vitamin D) |
Who may qualify
- Ages
- 21 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- End-stage renal disease undergoing maintenance hemodialysis at KUMC outpatient hemodialysis unit
- Dialysis vintage of at least 6 months duration
- Nutritional vitamin D deficiency, defined as 25(OH)D <25 ng/ml
- Age 21 to 88 years
Key exclusion criteria (11 listed)
- Active infection
- Recent hospitalization for acute illness (within last 1 month)
- Refusal to study participation
- Poorly controlled secondary hyperparathyroidism (iPTH>500)
- History of chronic inflammatory disease process, such as inflammatory bowel, rheumatoid arthritis, lupus, etc.
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D, ergocalciferol50,000 Units PO Twice weekly for 8 weeks | Drug | 1 |
Primary outcome
Change in Monocyte VDR Expression With Vitamin D Therapy
Time frame: Change from End of Washout to Week 12
Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20007751Stubbs JR, Idiculla A, Slusser J, Menard R, Quarles LD. Cholecalciferol supplementation alters calcitriol-responsive monocyte proteins and decreases inflammatory cytokines in ESRD. J Am Soc Nephrol. 2010 Feb;21(2):353-61. doi: 10.1681/ASN.2009040451. Epub 2009 Dec 10.
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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.
Jason Stubbs, MD principal investigator
University of Kansas Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with End-Stage Renal Disease, run by University of Kansas.
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 4 inclusion and 11 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 21 Mar 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?
Change in Monocyte VDR Expression With Vitamin D Therapy (time frame: Change from End of Washout to Week 12). 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 NCT00677534, which also lists 1 linked publication.
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 29 Apr 2014.