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

Kansas Board of Regents

Status

Completed

Conditions

End-Stage Renal Disease

Treatments

Drug: Cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT00677534

11225 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

All

Ages

21 to 88 years old

Volunteers

No Healthy Volunteers

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