Orthomolecular Therapy and Asthma in Children
Orthomolecular Treatment as add-on Therapy for Childhood Asthma
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Feb 2011
Typical duration for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2008
CompletedFirst Posted
Study publicly available on registry
May 6, 2008
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 4, 2011
February 1, 2011
2.1 years
May 5, 2008
February 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.
See primary endpoint
Study Arms (2)
Intervention Group
ACTIVE COMPARATORPlacebo Group
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Institute of Natural and Integrative Medicinelead
- Alberta Children's Hospitalcollaborator
- Alberta Health servicescollaborator
- Alberta Heritage Foundation for Medical Researchcollaborator
- SickKids Foundationcollaborator
- Lotte & John Hecht Memorial Foundationcollaborator
Study Sites (1)
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabine Moritz, MSc
Canadian Institute of Natural and Integrative Medicine
- PRINCIPAL INVESTIGATOR
Badri Rickhi, MB,BS,FRCPC
Canadian Institute of Natural and Integrative Medicine
- PRINCIPAL INVESTIGATOR
Hude Quan, MD, PhD
University of Calgary
- PRINCIPAL INVESTIGATOR
Sheldon Spier, MD,CM,FRCPC
Alberta Children's Hospital
- PRINCIPAL INVESTIGATOR
Mary Noseworthy, MD, FRCPC
Alberta Children's Hospital
- PRINCIPAL INVESTIGATOR
Eric Arrata, ND
Paradigm Health Group
- PRINCIPAL INVESTIGATOR
Trevor Hoffman, ND
Paradigm Health Group
- PRINCIPAL INVESTIGATOR
Paul Saunders, PhD, ND
Canadian College of Naturopathic Medicine
- PRINCIPAL INVESTIGATOR
Sunita Vohra, MD,FRCPC,MSc
University of Alberta
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 5, 2008
First Posted
May 6, 2008
Study Start
February 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 4, 2011
Record last verified: 2011-02