hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ishir Bhan, MD, MPH, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00742235

First received: August 25, 2008

Last updated: March 15, 2016

Last verified: March 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

August 25, 2008

Last Updated Date

March 15, 2016

Start Date ^ICMJE

July 2007

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

hCAP18 Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Baseline 25-OH Vitamin D Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

hCAP18 Levels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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 Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

January 2012

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

Gender

Both

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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