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hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Kidney Foundation
Information provided by (Responsible Party):
Ishir Bhan, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01026363
First received: December 2, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Vitamin D Deficiency
 Drug: Ergocalciferol
Drug: Calcitriol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • hCAP18 levels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1,25-dihydroxyvitamin D [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 25-hydroxyvitamin D [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • calcium [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • phosphorus [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Parathyroid hormone [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • T-cell subsets [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Measures of different types of T-cells


Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ergocalciferol
Ergocalciferol intervention arm
 Drug: Ergocalciferol
Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
Other Name: Vitamin D
Experimental: calcitriol
calcitriol intervention arm
 Drug: Calcitriol
0.25 mcg tablet once daily for 14 days
Other Name: vitamin d

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026363

Contacts
Contact: Dorothy Sullivan, RN 617-726-5382 DSULLIVAN18@PARTNERS.ORG
Contact: Ishir Bhan, MD MPH 617-726-3934 ibhan@partners.org

Locations
United States, Massachusetts
Massachusetts Institute of Technology Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Dorothy Sullivan, RN     617-726-5382     DSULLIVAN18@PARTNERS.ORG    
Principal Investigator: Ishir Bhan, MD MPH            
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Kidney Foundation
Investigators
Principal Investigator: Ishir Bhan, MD MPH Massachusetts General Hospital, Massachusetts Institute of Technology
  More Information

Publications:

Responsible Party: Ishir Bhan, MD, MPH, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01026363     History of Changes
Other Study ID Numbers: 2009-P-001050/1, 1K23DK081677
Study First Received: December 2, 2009
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Vitamin D
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Vitamin D Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency
Calcitriol
Ergocalciferols
Vitamin D
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013