Vitamin D in Pediatric Asthma: a Randomized Controlled Open-label Pilot Trial (D-Asthma)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Open Pilot of Low vs. Higher Dose Vitamin D in D-deficient Asthmatic Children: Does Diet Predict Immune Function and Asthma Symptom Response to Vitamin D Supplementation?|
- vitamin D levels [ Time Frame: change in serum vitamin D level from baseline to 12 weeks ] [ Designated as safety issue: Yes ]
1. 25-OH vitamin D (D2, D3): 1.0 ml sample sent to Esoterix Laboratory Services (Austin, TX) through NCH and run via high pressure liquid chromatography (HPLC), Tandem Mass Spectrometry analysis. Samples processed individually, not batched, for intervention study purposes.
- Side Effects Form for Children and Adolescents (SEFCA) [ Time Frame: Baseline, end of week 12 ] [ Designated as safety issue: Yes ]structured interviewer-administered questionnaire inquiring about body systems health and concerns
- Block Kids 2004 Food Frequency Questionnaire [ Time Frame: baseline, and end of week 12 ] [ Designated as safety issue: No ]a questionnaire inquiring how often children eat particular items from different food groups
- immune status [ Time Frame: baseline, and end of week 12 ] [ Designated as safety issue: No ]key pro-inflammatory and anti-inflammatory cytokines as well as T-cell ratios will be compared before and after vitamin D supplementation
- asthma severity [ Time Frame: baseline, and end of week 12 ] [ Designated as safety issue: No ]via pulmonary function tests
- quality of life [ Time Frame: Baseline, and end of week 12 ] [ Designated as safety issue: No ]pediatric quality of life questionnaire, including questions about asthma
- omega fatty acid profile [ Time Frame: Baseline, and end of week 12 ] [ Designated as safety issue: No ]red blood cells will be analyzed for omega fatty acid percentages and ratios of omega 3 fatty acids will be compared to omega 6 fatty acids.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: vitamin D2 + vitamin D3
Vitamin D2 50,000 IU each week x 4 + vitamin D3 4,000 IU each day for 3 months
Drug: Vitamin D2 + vitamin D3
higher dose vitamin D
Active Comparator: Vitamin D lower dose
800 IU vitamin D3 by mouth each day for 3 months
Drug: Vitamin D3
lower dose vitamin D
Other Name: Vitamin D3 800 IU by mouth each day for 3 months
An estimated up to 120 youth meeting eligibility criteria will be screened for vitamin D deficiency, and if found deficient, will be offered enrollment in this study.
Eligible children who assent and whose parent/guardian consent to participate will be randomized to low dose vs. higher dose vitamin D to take across a 3-month period of time. Blood, questionnaires, and pulmonary function tests will be obtained at baseline and end of study. Weekly phone calls will check on any questions or concerns the participant or their family may have.
Aims and Hypotheses:
Aim I: Evaluate effect sizes for relationships between omega-FA and vitD biomarkers, pre- and post- low and higher dose vitamin D supplementation, in diet, immune function, and asthma severity.
Aim II: Characterize changes in innate and adaptive immune function and inflammatory responses in asthmatic D-deficient youth at baseline and after vitD supplements, by O6:O3FA status and vitD dose.
Exploratory: Compute effect sizes/odds ratios for differences in pulmonary function, self-reported asthma severity, depressive symptoms, hospitalization/ED visits, and medication changes based on treatment group.
Effect sizes will be calculated for all continuous outcome variables by:
Effect Size (ES) = Average of the post-test scores - Average of the pre-test scores Average standard deviation
Odds ratios for the categorical asthma severity variable will be computed through logistic regression by treatment group with no covariates.
Examine differences in pulmonary function tests, self-reported asthma severity, depressive symptoms, hospitalization/ED visits, and medication changes based on treatment group. Omega fatty acid intake and allergic status will be included as potentially mediating variables.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02054975
|Contact: Barbara L. Gracious, MDfirstname.lastname@example.org|
|Contact: Sandy McBee-Strayer, PhD||614-355-3643||Sandy.McBee-Strayer@nationwidechildrens.org|
|United States, Ohio|
|Nationwide Children's Hospital||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Sandra McBee-Strayer, PhD email@example.com|
|Principal Investigator: Barbara L. Gracious, MD|
|Principal Investigator:||Barbara L Gracious, MD||Nationwide Children's Hospital|