hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Mass General Brigham

Status: Withdrawn

Conditions: Chronic Kidney Disease; Vitamin D Deficiency

Treatments: Drug: Calcitriol; Drug: Ergocalciferol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01026363

1K23DK081677 (U.S. NIH Grant/Contract)

2009-P-001050/1

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

ergocalciferol

Experimental group

Description:

Ergocalciferol intervention arm

Treatment:

Drug: Ergocalciferol

calcitriol

Experimental group

Description:

calcitriol intervention arm

Treatment:

Drug: Calcitriol