Vitamin and Asthma Study
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Dec 2010
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 3, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedOctober 23, 2012
October 1, 2012
9 months
October 3, 2011
October 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Pulmonary Function Test (PFT) after vitamin D supplementation
4 weeks
Change in Asthma Control Test (ACT) scores after vitamin D supplementation
4-week
Study Arms (2)
2000 IU vitamin D Daily
EXPERIMENTAL400 IU Vitamin D pill
PLACEBO COMPARATORInterventions
Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill
Eligibility Criteria
You may qualify if:
- History of asthma (under control)otherwise in good general health
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatrics Allergy Clinic at Georgia Health Sciences University
Augusta, Georgia, 30912, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 3, 2011
First Posted
October 6, 2011
Study Start
December 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 23, 2012
Record last verified: 2012-10