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

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Key information

Conditions

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

Age range

21 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cholecalciferol

Drug

50,000 Units PO Twice weekly for 8 weeks

Other names: Vitamin D, ergocalciferol

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: May 14, 2008
Registry last updated: Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed