Orthomolecular Therapy and Asthma in Children

Phase 2

• Conditions: Asthma
• Interventions: Dietary Supplement: Orthomolecular Therapy or Placebo Comparator

• Registration Number: NCT00672529
• Lead Sponsor: Canadian Institute of Natural and Integrative Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-06
• Status Verified: 2011-02
• Study Start: 2011-02
• Last Update Submitted: 2011-02-02
• Last Update Posted: 2011-02-04
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Male or female aged 7 to 18 years
• Mild to moderate asthma diagnosed by a respirologist
• Use of budesonide at a dose of 200-800 µg/d (or equivalent corticosteroid 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 3 months before enrollment in the run-in phase. Asthma symptoms must be under good control
• Baseline forced expiratory volume at 1 second (FEV-1) >= 70% of the predicted normal value.
• Possible participants treated with orthomolecular therapies within the previous year will require a wash out period of 7 days prior to enrolment in the trial. (Vitamin C > 200mg, Vitamin E >50IU, Vitamin B12 > 100µg, Magnesium > 200mg, Selenium > 50µg, Omega-3 > 300mg, Quercetin > 3mg, Vitamin B6 > 75mg will all be considered orthomolecular doses).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Orthomolecular Therapy or Placebo Comparator	-
Placebo Group	Orthomolecular Therapy or Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
The last tolerated dose of inhaled corticosteroids will be the primary end point.	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.

Secondary Outcome Measures

Name	Time	Method
The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.	See primary endpoint

Trial Locations

Locations (1)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada