hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

Tracking Information
First Submitted Date ICMJE	August 25, 2008
First Posted Date ICMJE	August 27, 2008
Results First Submitted Date	June 5, 2013
Results First Posted Date	November 11, 2013
Last Update Posted Date	April 14, 2016
Study Start Date ICMJE	July 2007
Actual Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 9, 2013)	hCAP18 Levels [ Time Frame: Baseline ]; Baseline 25-OH Vitamin D Level [ Time Frame: Baseline ]
Original Primary Outcome Measures ICMJE; (submitted: August 25, 2008)	hCAP18 Levels [ Time Frame: 2 weeks ]
Change History	Complete list of historical versions of study NCT00742235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
Official Title ICMJE	hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Healthy Subjects; Vitamin D Deficiency
Intervention ICMJE	Drug: ergocalciferol; Ergocalciferol 50,000 IU given every other day for 5 total doses; Other Name: Vitamin D
Study Arms	Experimental: 1 Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses) Intervention: Drug: ergocalciferol; No Intervention: Vitamin D sufficient Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level >32 ng/ml
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 9, 2013)	99
Original Estimated Enrollment ICMJE; (submitted: August 25, 2008)	100
Actual Study Completion Date	January 2012
Actual Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Age 18-80 Exclusion Criteria: Known active infectious disease or chronic inflammatory disorder; Hypercalcemia; Chronic kidney disease; Pregnancy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00742235
Other Study ID Numbers ICMJE	2008-P-0003000/1
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ishir Bhan, MD, MPH, Massachusetts General Hospital
Study Sponsor ICMJE	Massachusetts General Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Ishir Bhan, MD MPH Massachusetts General Hospital
PRS Account	Massachusetts General Hospital
Verification Date	March 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP