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hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742235
First Posted: August 27, 2008
Last Update Posted: April 14, 2016
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.
Information provided by (Responsible Party):
Ishir Bhan, MD, MPH, Massachusetts General Hospital
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Ishir Bhan, MD, MPH, Massachusetts General Hospital:

Primary Outcome Measures:
  • hCAP18 Levels [ Time Frame: Baseline ]
  • Baseline 25-OH Vitamin D Level [ Time Frame: Baseline ]

Enrollment: 99
Study Start Date: July 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses)
Drug: ergocalciferol
Ergocalciferol 50,000 IU given every other day for 5 total doses
Other Name: Vitamin D
No Intervention: Vitamin D sufficient
Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level >32 ng/ml

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00742235


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ishir Bhan, MD MPH Massachusetts General Hospital
  More Information

Responsible Party: Ishir Bhan, MD, MPH, Instructor in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00742235     History of Changes
Other Study ID Numbers: 2008-P-0003000/1
First Submitted: August 25, 2008
First Posted: August 27, 2008
Results First Submitted: June 5, 2013
Results First Posted: November 11, 2013
Last Update Posted: April 14, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents