We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01026363
Recruitment Status : Withdrawn (Inadequate enrollment)
First Posted : December 4, 2009
Last Update Posted : September 23, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Vitamin D Deficiency Drug: Ergocalciferol Drug: Calcitriol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
Study Start Date : December 2009
Primary Completion Date : July 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. hCAP18 levels [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. 1,25-dihydroxyvitamin D [ Time Frame: 2 weeks ]
  2. 25-hydroxyvitamin D [ Time Frame: 2 weeks ]
  3. calcium [ Time Frame: 2 weeks ]
  4. phosphorus [ Time Frame: 2 weeks ]
  5. Parathyroid hormone [ Time Frame: 2 weeks ]
  6. T-cell subsets [ Time Frame: 2 weeks ]
    Measures of different types of T-cells

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Ishir Bhan, MD, MPH, Massachusetts General Hospital:
Vitamin D
Chronic Kidney Disease

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