hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
1 other identifier
interventional
99
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
November 11, 2013
CompletedApril 14, 2016
March 1, 2016
4.5 years
August 25, 2008
June 5, 2013
March 15, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
hCAP18 Levels
Baseline
Baseline 25-OH Vitamin D Level
Baseline
Study Arms (2)
1
EXPERIMENTALVitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses)
Vitamin D sufficient
NO INTERVENTIONSubjects who did not receive ergocalciferol and had a 25-OH vitamin D level \>32 ng/ml
Interventions
Ergocalciferol 50,000 IU given every other day for 5 total doses
Eligibility Criteria
You may qualify if:
- Age 18-80
You may not qualify if:
- Known active infectious disease or chronic inflammatory disorder
- Hypercalcemia
- Chronic kidney disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Ishir Bhan, MD MPH
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor in Medicine
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 27, 2008
Study Start
July 1, 2007
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
April 14, 2016
Results First Posted
November 11, 2013
Record last verified: 2016-03