Vitamin and Asthma Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01447173
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : October 23, 2012
Information provided by (Responsible Party):
Yanbin Dong, Augusta University

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Vitamin D Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Change in Pulmonary Function Test (PFT) after vitamin D supplementation [ Time Frame: 4 weeks ]
  2. Change in Asthma Control Test (ACT) scores after vitamin D supplementation [ Time Frame: 4-week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01447173

United States, Georgia
Pediatrics Allergy Clinic at Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University

Responsible Party: Yanbin Dong, Professor, Augusta University Identifier: NCT01447173     History of Changes
Other Study ID Numbers: VDAS
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Yanbin Dong, Augusta University:
Pulmonary Function Test
Vitamin D

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents