drugset / Trial / NCT02054975

Vitamin D in Pediatric Asthma: a Randomized Controlled Open-label Pilot Trial

NCT02054975

RandomizedParallel-groupOpen-labelTreatment

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: 1. 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. 2. 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.

Timeline

Start
2014-01
Primary completion
2015-09
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 800 iu Oral
Subject Cholecalciferol Other / unclassified 4000 iu Oral
Subject Ergocalciferol Small molecule 50000 iu Oral