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hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

NCT ID: NCT00742235

Last Updated: 2016-04-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects Vitamin D Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses)

Group Type EXPERIMENTAL

ergocalciferol

Intervention Type DRUG

Ergocalciferol 50,000 IU given every other day for 5 total doses

Vitamin D sufficient

Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level \>32 ng/ml

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ergocalciferol

Ergocalciferol 50,000 IU given every other day for 5 total doses

Intervention Type DRUG

Other Intervention Names

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Vitamin D

Eligibility Criteria

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Inclusion Criteria

* Age 18-80

Exclusion Criteria

* Known active infectious disease or chronic inflammatory disorder
* Hypercalcemia
* Chronic kidney disease
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ishir Bhan, MD, MPH

Instructor in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ishir Bhan, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008-P-0003000/1

Identifier Type: -

Identifier Source: org_study_id

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