Official Title: “Orthomolecular Treatment as Add-on Therapy for Childhood Asthma”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: Orthomolecular Therapy (Vitamins C, E, B6 and B12, magnesium, selenium, quercitin and fish oil)
  • The custom formulation proposed in this study comprises Vitamins C, E, B6 and B12, magnesium, selenium, quercitin and fish oil in relatively large doses. It is not at present registered as a natural health product or drug product

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Placebo Comparator: B
  • Nutritional supplement as add-on therapy versus placebo

Primary Measures

• The last tolerated dose of inhaled corticosteroids will be the primary end point.
  • Time Frame: To safeguard against the possibility of excessive adverse events related to the tapering procedures or the orthomolecular treatment, an interim analysis will be conducted after 50% accrual is reached in this pilot investigation.
    Safety Issue?: Yes

Secondary Measures

• The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.
  • Time Frame: See primary endpoint
    Safety Issue?: Yes

Inclusion Criteria:

• Male or female aged 7 to 18 years.
• Moderate to severe asthma of at least 1 year's duration diagnosed by a respirologist.
• Use of budesonide at a dose of 400-800 µg/d (or equivalent corticostertoid therapy) for ≥3 months.
• Stable asthma, defined as no significant change in the regular asthma medication and no acute asthma exacerbation requiring corticosteroid rescue for at least 4 weeks before enrollment in the run-in phase.
• Baseline forced expiratory volume at 1 second (FEV-1) 60% of the predicted normal value.

Exclusion Criteria:

• Previous treatment with orthomolecular therapy within 1 year of commencement of the CT.
• Known hypersensitivity to any component of the orthomolecular therapy or placebo.
• Acute infectious sinusitis or respiratory tract infection or active lung disease other than allergic asthma within 1 month or any other significant systemic disease within 3 months of the study entry visit.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 7 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Canadian Institute of Natural and Integrative Medicine

Overall Clinical Trial Officials and Contacts

Sabine Moritz, MSc Principal Investigator Canadian Institute of Natural and Integrative Medicine  

Overall Contact: Sabine Moritz (403) 220-0022 s.moritz@cinim.org

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00672529

Study ID Number: 18376

ClinicalTrials.gov Identifier: NCT00672529

Health Authority: Canada: Health Canada

Canadian Institute of Natural and Integrative Medicine, Calgary