Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2011-02-28
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
NCT00006565
Management of Asthma in School-age Children on Therapy
NCT01526161
Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia
NCT01326494
Asthma in Children
NCT01286532
Traditional Chinese Medicine in Management of Childhood Asthma
NCT03645889
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
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.
Placebo Group
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
7 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alberta Children's Hospital
OTHER
Alberta Health services
OTHER
Alberta Heritage Foundation for Medical Research
OTHER
SickKids Foundation
OTHER
Lotte & John Hecht Memorial Foundation
OTHER
Canadian Institute of Natural and Integrative Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Canadian Institute of Natural and Integrative Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sabine Moritz, MSc
Role: PRINCIPAL_INVESTIGATOR
Canadian Institute of Natural and Integrative Medicine
Badri Rickhi, MB,BS,FRCPC
Role: PRINCIPAL_INVESTIGATOR
Canadian Institute of Natural and Integrative Medicine
Hude Quan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Sheldon Spier, MD,CM,FRCPC
Role: PRINCIPAL_INVESTIGATOR
Alberta Children's Hospital
Mary Noseworthy, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Alberta Children's Hospital
Eric Arrata, ND
Role: PRINCIPAL_INVESTIGATOR
Paradigm Health Group
Trevor Hoffman, ND
Role: PRINCIPAL_INVESTIGATOR
Paradigm Health Group
Paul Saunders, PhD, ND
Role: PRINCIPAL_INVESTIGATOR
Canadian College of Naturopathic Medicine
Sunita Vohra, MD,FRCPC,MSc
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alberta Children's Hospital
Calgary, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Canadian Institute of Natural and Integrative Medicine, Calgary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NHPD 115797
Identifier Type: -
Identifier Source: secondary_id
18376
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.