Back to resultshCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
Primary Purpose
Healthy Subjects, Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ergocalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Subjects
Eligibility Criteria
Inclusion Criteria:
- Age 18-80
Exclusion Criteria:
- Known active infectious disease or chronic inflammatory disorder
- Hypercalcemia
- Chronic kidney disease
- Pregnancy
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
Vitamin D sufficient
Arm Description
Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses)
Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level >32 ng/ml
Outcomes
Primary Outcome Measures
hCAP18 Levels
Baseline 25-OH Vitamin D Level
Secondary Outcome Measures
Full Information
NCT ID
NCT00742235
First Posted
August 25, 2008
Last Updated
March 15, 2016
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00742235
Brief Title
hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
Official Title
hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses)
Arm Title
Vitamin D sufficient
Arm Type
No Intervention
Arm Description
Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level >32 ng/ml
Intervention Type
Drug
Intervention Name(s)
ergocalciferol
Other Intervention Name(s)
Vitamin D
Intervention Description
Ergocalciferol 50,000 IU given every other day for 5 total doses
Primary Outcome Measure Information:
Title
hCAP18 Levels
Time Frame
Baseline
Title
Baseline 25-OH Vitamin D Level
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-80
Exclusion Criteria:
Known active infectious disease or chronic inflammatory disorder
Hypercalcemia
Chronic kidney disease
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ishir Bhan, MD MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
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