Chronic Kidney Disease, Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Chronic Kidney Disease
Brief summary
The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. This study is designed to test the ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18 levels will be measured during an initial visit. Individuals who are vitamin D deficient will be randomly assigned to receive one of two forms of vitamin D for two weeks. After this, follow-up levels will be measured.
Interventions
DRUGErgocalciferol
Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
DRUGCalcitriol
0.25 mcg tablet once daily for 14 days
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Kidney Foundation, United States
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 * Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min)
Exclusion criteria
* 6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis * use of active vitamin D analog within 30 days * functioning renal transplant * Symptoms of active infection * Granulomatous disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hCAP18 levels | 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 25-hydroxyvitamin D | 2 weeks | — |
| calcium | 2 weeks | — |
| 1,25-dihydroxyvitamin D | 2 weeks | — |
| Parathyroid hormone | 2 weeks | — |
| T-cell subsets | 2 weeks | Measures of different types of T-cells |
| phosphorus | 2 weeks | — |
Countries
United States
Outcome results
None listed