NCT00672529

Orthomolecular Therapy and Asthma in Children

Orthomolecular Treatment as add-on Therapy for Childhood Asthma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Canadian Institute of Natural and Integrative Medicine · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Orthomolecular Therapy or Placebo Comparator	The custom formulation proposed in this study comprises Vitamins C, E, B6 and B12, magnesium, selenium, quercetin and fish oil in relatively large doses. It is not at present registered as a natural health product or drug product. Eligible patients will be randomized to an orthomolecular treatment regime or placebo with a 2:1 randomization ratio and will remain on their randomized treatment for 16 weeks. For the first 8 weeks of the intervention period inhaled corticosteroid treatment will be unchanged. In the remaining 8 weeks dose adjustment will occur every two weeks. Participants will be monitored closely for changes in their lung function.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2008-05-06
• Last updated: 2011-02-04

Locations

1 site across 1 country: Canada