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Randomized Controlled Trial of Vitamin D3 Supplementation for Viral Upper Respiratory Tract Infections (URI) Prevention

NCT ID: NCT00656929

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-06-30

Brief Summary

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Background: Vitamin D has been shown to be an important immune system regulator. Vitamin D insufficiency during the winter may cause increased susceptibility to infections, particularly viral upper respiratory tract infections (URIs).

Objective: To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms in adults.

Methods: A randomized, double-blind, placebo-controlled trial was conducted in 162 adults. Participants were randomized to receive vitamin D3 50 mcg (2000 IU) daily or matching placebo for 12 weeks from December 2006 to March 2007. A biweekly questionnaire was used to record the incidence and severity of URI symptoms

Detailed Description

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Conditions

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Viral Upper Respiratory Tract Infection

Keywords

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Vitamin D Viral URI Influenza Colds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Vitamin D3 50 mcg (2000 IU) daily

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months

2

Placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets

Interventions

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Vitamin D3

Vitamin D3 (cholecalciferol) 50 mcg (2000 IU) daily x 3 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo tablets

Intervention Type OTHER

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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Inclusion Criteria

* ambulatory adult age 18-80 and stable medical condition with no change in medications for 6 months prior to study entry.

Exclusion Criteria

* morbid obesity (body mass index \> 35 kg/m2)
* current tobacco use
* history of hypercalcemia, nephrolithiasis or sarcoidosis
* pregnancy
* recent hospitalization
* current liver or kidney disorders, malignancy and malabsorption
* use of immunosuppressants or medications that interfere with vitamin D metabolism such as phenytoin and carbamazepine.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Winthrop University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Winthrop University Hospital

Principal Investigators

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John F Aloia, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Other Identifiers

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WUH06034

Identifier Type: -

Identifier Source: org_study_id