The Role of Vitamin D in Immune Function in Patients With Chronic Kidney Disease (CKD) Stages 3 and 4.
The Role of Vitamin D in Immune Function in Patients With CKD Stages 3 and 4.
Patients with chronic kidney disease (CKD) are commonly deficient in vitamin D, with low levels of both calcidiol (25 hydroxy vitamin D) and calcitriol (1,25-hydroxy vitamin D). Patients with CKD are also known to have abnormalities in their immune cells, increased susceptibility to infection and increased prevalence of malignancies. In patients without kidney disease, repletion of vitamin D appears to help some immune mediated diseases. Thus it is logical that patients with CKD who are vitamin D deficient may benefit from repletion of vitamin D, in either its native form (cholecalciferol/ergocalciferol) or in the form of calcitriol or its analogues. However, no interventional data demonstrates that repletion positively impacts immune status in CKD patients. To test this hypothesis, a large interventional study will be required. However, prior to conducting this study, several important steps are needed. The present proposal aims to generate the necessary data to appropriately plan and conduct a future multi center interventional study. Specifically, we will examine the following specific aims in a population of CKD stage 3 and 4 subjects from Indiana University Affiliated Nephrology Clinics and determine
- if abnormalities in immune cells and immune blood tests are related to abnormalities in vitamin D.
- how reproducible these changes are on repeat testing and
- if repletion of vitamin D changes these cells and immune blood tests in a small pilot study.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- no administration of any form of vitamin D supplement or therapy in the last 60 days except for that in a multi vitamin
- Hgb >10 mg/dl
- able to sign informed consent
- CKD stage 3 (GFR 30-59ml/min) or stage 4 (GFR 15-29ml/min)
- iPTH <70pg/ml for stage 3 or iPTH <110pg/ml for stage 4
- calcidiol levels < or +20ng/ml
Exclusion Criteria:
- initial corrected Calcium >9.7mg/dl
- initial serum Phosphorus >5.0mg/dl
- initial standardized blood pressure of >160/100
- history of significant liver disease or cirrhosis
- anticipated requirement for dialysis in 6 months
- malabsorption, severe chronic diarrhea, or ileostomy
- no calcimimetic or active vitamin D therapy 60 days prior to enrollment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 1
4000 IU of cholecalciferol per day
|
4000 IU of cholecalciferol per day 15 patients will be enrolled in each arm. |
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Comparador activo: 2
1 mcg of doxercalciferol per day.
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1 mcg of doxercalciferol per day
|
|
Comparador de placebos: 3
placebo for six months
|
placebo for 6 months; with stratification based on stage of CKD by modified MDRD formula. 15 patients will be enrolled in each arm. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The primary endpoint will be the change in CD4+/CD8+ ratio and other flow cytometry parameters based on the results of Aims 1 and 2, TH1/TH2 cytokine profile, and conversion from anergic to reactive skin testing.
Periodo de tiempo: 6 months from baseline visit
|
6 months from baseline visit
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
A change in mean blood pressure from one week of ambulatory measures, random protein/creatinine ratio, and differences in muscle strength by timed up and go test, and measures of quality of life using the SF36 forms.
Periodo de tiempo: 6 months from baseline visit.
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6 months from baseline visit.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sharon M Moe, MD, Indiana University School of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0707-04
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