hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Official Title: “hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease”

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.

Intervention(s) in this Clinical Trial

• Drug: Ergocalciferol
  • Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
• Drug: Calcitriol
  • 0.25 mcg tablet once daily for 14 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: ergocalciferol
  • Ergocalciferol intervention arm
• Experimental: calcitriol
  • calcitriol intervention arm

Primary Measures

• hCAP18 levels
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• 1,25-dihydroxyvitamin D
  • Time Frame: 2 weeks
    Safety Issue?: No
• 25-hydroxyvitamin D
  • Time Frame: 2 weeks
    Safety Issue?: No
• calcium
  • Time Frame: 2 weeks
    Safety Issue?: Yes
• phosphorus
  • Time Frame: 2 weeks
    Safety Issue?: Yes
• Parathyroid hormone
  • Time Frame: 2 weeks
    Safety Issue?: No
• T-cell subsets
  • Time Frame: 2 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Massachusetts General Hospital Other

Overall Clinical Trial Officials and Contacts

Ishir Bhan, MD MPH Principal Investigator Massachusetts General Hospital, Massachusetts Institute of Technology  

Overall Contact: Dorothy Sullivan, RN 617-726-5382 DSULLIVAN18@PARTNERS.ORG

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01026363

Study ID Number: 2009-P-001050/1

ClinicalTrials.gov Identifier: NCT01026363

Health Authority: United States: Institutional Review Board