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Vitamin

vitamin D2 + vitamin D3 for Asthma (D-Asthma Trial)

N/A
Waitlist Available
Led By Barbara L Gracious, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of week 12
Awards & highlights

D-Asthma Trial Summary

This is a pilot randomized controlled trial of lower vs. higher dose vitamin D supplementation in D-deficient asthmatic children, to determine necessary sample sizes for outcome measures in a larger multisite study, and to examine possible relationships and effect sizes between various biological markers that may be important to the pathophysiology of childhood asthma. Aims of the study are to: Evaluate effect sizes for relationships between serum 25OH-vitD and omega-fatty acid (FA) biomarkers, before and after supplementation with lower or higher dose vitamin D, on immune function, and asthma severity. Characterize changes in innate and adaptive immune function and inflammatory responses in asthmatic D-deficient youth at baseline and after vitD supplements, by dietary O6:O3FA status and vitD dose.

Eligible Conditions
  • Asthma
  • Vitamin D Deficiency

D-Asthma Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
vitamin D levels
Secondary outcome measures
Block Kids 2004 Food Frequency Questionnaire
Side Effects Form for Children and Adolescents (SEFCA)
immune status
Other outcome measures
asthma severity
omega fatty acid profile
quality of life

D-Asthma Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: vitamin D2 + vitamin D3Experimental Treatment1 Intervention
Vitamin D2 50,000 IU each week x 4 + vitamin D3 4,000 IU each day for 3 months
Group II: Vitamin D lower doseActive Control1 Intervention
800 IU vitamin D3 by mouth each day for 3 months

Find a Location

Who is running the clinical trial?

Ohio State UniversityOTHER
829 Previous Clinical Trials
505,725 Total Patients Enrolled
8 Trials studying Asthma
465 Patients Enrolled for Asthma
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,485 Total Patients Enrolled
3 Trials studying Asthma
110 Patients Enrolled for Asthma
Barbara L Gracious, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
65 Total Patients Enrolled

Frequently Asked Questions

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~2 spots leftby Apr 2025