Orthomolecular Therapy and Asthma in Children

Asthma Clinical Trial

Official title: Orthomolecular Treatment as add-on Therapy for Childhood Asthma

Status Recruiting

Clinical Trial Summary

The purpose of this study is

1. To pilot the research methodology for a randomized trial on an orthomolecular treatment regime versus placebo as add-on therapy for children with asthma;

2. To obtain a preliminary estimate of the effectiveness of an orthomolecular treatment regime for allowing tapering of inhaled corticosteroids in clinically stable asthmatic children. The obtained estimate will allow sample size calculations for a full-scale randomized trial; and

3. To obtain preliminary information about the safety and tolerability of an orthomolecular treatment regime.

Clinical Trial Description

An orthomolecular treatment approach that combines supplements has, to date, not been tested, although it is commonly used by naturopathic practitioners to treat respiratory problems in individual children. A well-designed controlled trial is needed to determine if this approach is effective. This smaller study should establish guidelines for a large trial to follow. This proposed research is particularly important, as the trend to use natural treatments may encourage non-compliance with conventional medical treatments, leading to poor asthma control. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT00672529
• Study type: Interventional
• Source: Canadian Institute of Natural and Integrative Medicine
• Contact: Sabine Moritz, MSc
• Phone: (403) 220-0022
• Email: s.moritz@cinim.org
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2011
• Completion date: March 2013