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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Recruitment Status : Withdrawn (Inadequate enrollment)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
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

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 Phase
Chronic Kidney Disease Vitamin D Deficiency Drug: Ergocalciferol Drug: Calcitriol Not Applicable

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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
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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

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


Locations
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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
Investigators
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Principal Investigator: Ishir Bhan, MD MPH Massachusetts General Hospital, Massachusetts Institute of Technology
Publications:
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Responsible Party: Ishir Bhan, MD, MPH, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01026363    
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Vitamin D Deficiency
Urologic Diseases
Renal Insufficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Calcitriol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents