Vitamin and Asthma Study

October 22, 2012 updated by: Yanbin Dong, Augusta University
The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Pediatrics Allergy Clinic at Georgia Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of asthma (under control)otherwise in good general health

Exclusion Criteria:

  • Poorly controlled asthma
  • Taking daily multivitamin or vitamin D supplementation
  • Taking oral steroid medication
  • History of bronchopulmonary dysplasia or chronic lung disease, extreme prematurity, congenital heart disease, significant renal dysfunction or primary kidney disease, endocrinologic abnormalities of calcium metabolism or parathyroid disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2000 IU vitamin D Daily
Drug: Vitamin D
Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill
Placebo Comparator: 400 IU Vitamin D pill
Drug: Vitamin D
Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Pulmonary Function Test (PFT) after vitamin D supplementation
Time Frame: 4 weeks
4 weeks
Change in Asthma Control Test (ACT) scores after vitamin D supplementation
Time Frame: 4-week
4-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 22, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VDAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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