hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

NCT ID: NCT01026363

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Chronic Kidney Disease; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ergocalciferol

Ergocalciferol intervention arm

Group Type: EXPERIMENTAL

Ergocalciferol

Intervention Type: DRUG

Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses

calcitriol

calcitriol intervention arm

Group Type: EXPERIMENTAL

Calcitriol

Intervention Type: DRUG

0.25 mcg tablet once daily for 14 days

Interventions

Ergocalciferol

Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses

Intervention Type: DRUG

Calcitriol

0.25 mcg tablet once daily for 14 days

Intervention Type: DRUG

Other Intervention Names

Vitamin D; vitamin d

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

National Kidney Foundation, United States

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ishir Bhan, MD, MPH

Assistant in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ishir Bhan, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital, Massachusetts Institute of Technology

Locations

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19133797 (View on PubMed)

Other Identifiers

1K23DK081677

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009-P-001050/1

Identifier Type: -

Identifier Source: org_study_id