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hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, August 2008
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00742235
  Purpose

Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently discovered protein, called hCAP18, likely plays an important role in the immune system and may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are needed to allow the body to make this protein. Nor is it known if giving vitamin D to people who are found to be deficient will help boost levels of hCAP18. This study aims to clarify the relationship between vitamin D levels and hCAP18.


Condition Intervention
Healthy Subjects
Vitamin D Deficiency
Drug: ergocalciferol

Drug Information available for: Vitamin D Ergocalciferol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

Further study details as provided by Massachusetts General Hospital:

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

Estimated Enrollment: 100
Study Start Date: July 2007
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Vitamin D deficient subjects treated with ergocalciferol.
Drug: ergocalciferol
Ergocalciferol 50,000 IU given every other day for 5 total doses

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-80

Exclusion Criteria:

  • Known active infectious disease or chronic inflammatory disorder
  • Hypercalcemia
  • Chronic kidney disease
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742235

Contacts
Contact: Ishir Bhan, M.D., M.P.H. 617-726-3934 ibhan@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Dorothy Sullivan, RN     617-726-5382     DSULLIVAN18@PARTNERS.ORG    
Principal Investigator: Ishir Bhan, M.D., M.P.H.            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ishir Bhan, MD MPH Massachusetts General Hospital
  More Information

Responsible Party: Massachusetts General Hospital ( Ishir Bhan )
Study ID Numbers: 2008-P-0003000/1
Study First Received: August 25, 2008
Last Updated: August 25, 2008
ClinicalTrials.gov Identifier: NCT00742235  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Vitamin D Deficiency
Vitamin D
Malnutrition
Avitaminosis
Ergocalciferols
Nutrition Disorders
Healthy
Deficiency Diseases

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009