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
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Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Ishir Bhan, MD, MPH, Massachusetts General Hospital
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE |
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 |
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Condition ICMJE |
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Intervention ICMJE | Drug: ergocalciferol
Ergocalciferol 50,000 IU given every other day for 5 total doses
Other Name: Vitamin D |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
99 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |