AsthmaPhase 2NCT00672529
Orthomolecular Therapy and Asthma in Children
A Phase 2 study of Asthma, run by Canadian Institute of Natural and Integrative Medicine at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Asthma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Sheldon Spier
About this study
Official title: Orthomolecular Treatment as add-on Therapy for Childhood Asthma
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Orthomolecular Therapy or Placebo Comparator
- Keywords
- Childhood Asthma, Inhaled Corticosteroids, Alternative Medicine, Vitamins, minerals, and fish oil as Add-on Treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthomolecular Therapy or Placebo ComparatorDietary supplement
Also called CIN-AST-01
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Not described Receives: Dietary Supplement: Orthomolecular Therapy or Placebo Comparator |
| Placebo Group | Placebo comparator | Not described Receives: Dietary Supplement: Orthomolecular Therapy or Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The last tolerated dose of inhaled corticosteroids will be the primary end point.
Measured: 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.
Measured: See primary endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startFeb 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Institute of Natural and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital, Alberta Health services, Alberta Heritage Foundation for Medical Research, SickKids Foundation, Lotte & John Hecht Memorial Foundation
- Investigators
- Sabine Moritz, MSc, Principal investigator, Canadian Institute of Natural and Integrative MedicineBadri Rickhi, MB,BS,FRCPC, Principal investigator, Canadian Institute of Natural and Integrative MedicineHude Quan, MD, PhD, Principal investigator, University of CalgarySheldon Spier, MD,CM,FRCPC, Principal investigator, Alberta Children's HospitalMary Noseworthy, MD, FRCPC, Principal investigator, Alberta Children's HospitalEric Arrata, ND, Principal investigator, Paradigm Health GroupTrevor Hoffman, ND, Principal investigator, Paradigm Health GroupPaul Saunders, PhD, ND, Principal investigator, Canadian College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672529
- Sponsor's protocol ID
- 18376
- Other IDs
- NHPD 115797
- Status last verified
- Feb 2011
- First submitted
- 5 May 2008
- Last updated
- 4 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthomolecular Treatment as add-on Therapy for Childhood Asthma
- ClinicalTrials.gov ID
- NCT00672529
- Acronym / sponsor ID
- 18376
- Conditions
- Asthma
- Keywords
- Childhood Asthma, Inhaled Corticosteroids, Alternative Medicine, Vitamins, minerals, and fish oil as Add-on Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Canadian Institute of Natural and Integrative MedicineUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital, Alberta Health services, Alberta Heritage Foundation for Medical Research, SickKids Foundation, Lotte & John Hecht Memorial Foundation
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Dietary Supplement: Orthomolecular Therapy or Placebo Comparator |
| Placebo Group | Placebo comparator | Dietary Supplement: Orthomolecular Therapy or Placebo Comparator |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthomolecular Therapy or Placebo ComparatorAlso: CIN-AST-01The 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. | Dietary supplement | Intervention Group, Placebo Group |
Primary outcome
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.
1 secondary outcome
The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.
Time frame: See primary endpoint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2011.
- Canadian Institute of Natural and Integrative Medicine, CalgaryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Moritz, MSc principal investigator
Canadian Institute of Natural and Integrative Medicine
Badri Rickhi, MB,BS,FRCPC principal investigator
Canadian Institute of Natural and Integrative Medicine
Hude Quan, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Asthma, run by Canadian Institute of Natural and Integrative Medicine at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Moritz, MSc ((403) 220-0022 ext. 103, s.moritz@cinim.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2011.