hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01026363
• Other study ID #: 2009-P-001050/1
• Secondary ID: 1K23DK081677
• Status: Withdrawn
• Phase: N/A
• First received: December 2, 2009
• Last updated: September 21, 2015
• Start date: December 2009
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts Institute of Technology	Cambridge	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Kidney Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gombart AF, Bhan I, Borregaard N, Tamez H, Camargo CA Jr, Koeffler HP, Thadhani R. Low plasma level of cathelicidin antimicrobial peptide (hCAP18) predicts increased infectious disease mortality in patients undergoing hemodialysis. Clin Infect Dis. 2009 Feb 15;48(4):418-24. doi: 10.1086/596314. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hCAP18 levels		2 weeks	No
Secondary	1,25-dihydroxyvitamin D		2 weeks	No
Secondary	25-hydroxyvitamin D		2 weeks	No
Secondary	calcium		2 weeks	Yes
Secondary	phosphorus		2 weeks	Yes
Secondary	Parathyroid hormone		2 weeks	No
Secondary	T-cell subsets	Measures of different types of T-cells	2 weeks	No