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NCT01447173 Clinical Trial

Vitamin and Asthma Study

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01447173
Other study ID # VDAS
Secondary ID
Status Completed
Phase Phase 4
First received October 3, 2011
Last updated October 22, 2012
Start date December 2010
Est. completion date September 2011

Study information
Verified date October 2012
Source Georgia Regents University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D
Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill

Locations
Country Name City State
United States Pediatrics Allergy Clinic at Georgia Health Sciences University Augusta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Georgia Regents University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Pulmonary Function Test (PFT) after vitamin D supplementation 4 weeks No
Primary Change in Asthma Control Test (ACT) scores after vitamin D supplementation 4-week No
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