Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease

NCT00677534 | Completed Results

• 1 other identifier: 11225
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

End-Stage Renal Disease

Keywords

Endstage renal disease; Vitamin D; Monocyte function

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from End of Washout to Week 12

Study Arms (1)

1

EXPERIMENTAL

Cholecalciferol (Vitamin D)

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

50,000 Units PO Twice weekly for 8 weeks

Also known as: Vitamin D, ergocalciferol

1

Eligibility Criteria

• Age: 21 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Kansas: lead

Related Publications (1)

• 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.

  PMID: 20007751 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Cholecalciferol; Ergocalciferols

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

Limitations and Caveats

This was a pilot study using a small number of patients. Further studies are needed to validate these findings in larger groups of patients.

Results Point of Contact

• Title: Dr. Jason Stubbs
• Organization: University of Kansas Medical Center

jstubbs@kumc.edu

913-588-3867

Study Officials

• Jason Stubbs, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 29, 2014
• Results First Posted: March 21, 2014

Record last verified: 2014-04