hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

This study has been withdrawn prior to enrollment.
(Inadequate enrollment)
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:
First received: December 2, 2009
Last updated: September 21, 2015
Last verified: September 2015
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:

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

Enrollment: 0
Study Start Date: December 2009
Study Completion Date: December 2014
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


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026363

United States, Massachusetts
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Kidney Foundation
Principal Investigator: Ishir Bhan, MD MPH Massachusetts General Hospital, Massachusetts Institute of Technology
  More Information

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: September 21, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Renal Insufficiency
Urologic Diseases
Vitamin D
Bone Density Conservation Agents
Calcium Channel Agonists
Growth Substances
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on May 25, 2016