Back to resultsOrthomolecular Therapy and Asthma in Children
Primary Purpose
Asthma
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Orthomolecular Therapy or Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Childhood Asthma, Inhaled Corticosteroids, Alternative Medicine, Vitamins, minerals, and fish oil as Add-on Treatment
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.
Sites / Locations
- Alberta Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention Group
Placebo Group
Arm Description
Outcomes
Primary Outcome Measures
The last tolerated dose of inhaled corticosteroids will be the primary end point.
Secondary Outcome Measures
The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.
Full Information
NCT ID
NCT00672529
First Posted
May 5, 2008
Last Updated
February 2, 2011
Sponsor
Canadian Institute of Natural and Integrative Medicine
Collaborators
Alberta Children's Hospital, Alberta Health services, Alberta Heritage Foundation for Medical Research, SickKids Foundation, Lotte & John Hecht Memorial Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00672529
Brief Title
Orthomolecular Therapy and Asthma in Children
Official Title
Orthomolecular Treatment as add-on Therapy for Childhood Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Canadian Institute of Natural and Integrative Medicine
Collaborators
Alberta Children's Hospital, Alberta Health services, Alberta Heritage Foundation for Medical Research, SickKids Foundation, Lotte & John Hecht Memorial Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is
To pilot the research methodology for a randomized trial on an orthomolecular treatment regime versus placebo as add-on therapy for children with asthma;
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Childhood Asthma, Inhaled Corticosteroids, Alternative Medicine, Vitamins, minerals, and fish oil as Add-on Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Orthomolecular Therapy or Placebo Comparator
Other Intervention Name(s)
CIN-AST-01
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.
Time Frame
See primary endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Moritz, MSc
Phone
(403) 220-0022
Ext
103
Email
s.moritz@cinim.org
First Name & Middle Initial & Last Name or Official Title & Degree
Asthma Trial Coordinator
Phone
(403) 220-0022
Ext
106
Email
asthma@cinim.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Moritz, MSc
Organizational Affiliation
Canadian Institute of Natural and Integrative Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Badri Rickhi, MB,BS,FRCPC
Organizational Affiliation
Canadian Institute of Natural and Integrative Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hude Quan, MD, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheldon Spier, MD,CM,FRCPC
Organizational Affiliation
Alberta Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Noseworthy, MD, FRCPC
Organizational Affiliation
Alberta Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Arrata, ND
Organizational Affiliation
Paradigm Health Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trevor Hoffman, ND
Organizational Affiliation
Paradigm Health Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Saunders, PhD, ND
Organizational Affiliation
Canadian College of Naturopathic Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sunita Vohra, MD,FRCPC,MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheldon Spier
12. IPD Sharing Statement
Links:
URL
http://www.cinim.org/
Description
Canadian Institute of Natural and Integrative Medicine, Calgary
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Orthomolecular Therapy and Asthma in Children
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