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hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00742235
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : November 11, 2013
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Healthy Subjects Vitamin D Deficiency Drug: ergocalciferol

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
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
Study Start Date : July 2007
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

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

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

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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 Posted: August 27, 2008    Key Record Dates
Results First Posted: November 11, 2013
Last Update Posted: April 14, 2016
Last Verified: March 2016

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