Clinical trial NCT00672529: Orthomolecular Therapy and Asthma in Children
Official title: Orthomolecular Treatment as add-on Therapy for Childhood Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Asthma
Keywords: Childhood Asthma
Inhaled Corticosteroids
Alternative Medicine
Vitamins, minerals, and fish oil as Add-on Treatment
Lead sponsor: Canadian Institute of Natural and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: Alberta Children's Hospital
name: Alberta Health services
name: Alberta Heritage Foundation for Medical Research
name: SickKids Foundation
name: Lotte & John Hecht Memorial Foundation
First posted: 2008-05-06
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The last tolerated dose of inhaled corticosteroids will be the primary end point.
timeFrame: 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 outcomes:
measure: The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.
timeFrame: See primary endpoint
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: Canadian Institute of Natural and Integrative Medicine
name: Sabine Moritz, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Institute of Natural and Integrative Medicine
name: Badri Rickhi, MB,BS,FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Hude Quan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Children's Hospital
name: Sheldon Spier, MD,CM,FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Children's Hospital
name: Mary Noseworthy, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Paradigm Health Group
name: Eric Arrata, ND
role: PRINCIPAL_INVESTIGATOR
affiliation: Paradigm Health Group
name: Trevor Hoffman, ND
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian College of Naturopathic Medicine
name: Paul Saunders, PhD, ND
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Sunita Vohra, MD,FRCPC,MSc
role: PRINCIPAL_INVESTIGATOR
References: