Orthomolecular Therapy and Asthma in Children

Asthma Clinical Trial

Official title:

Orthomolecular Treatment as add-on Therapy for Childhood Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00672529
• Other study ID #: 18376
• Secondary ID: NHPD 115797
• Status: Recruiting
• Phase: Phase 2
• First received: May 5, 2008
• Last updated: February 2, 2011
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: February 2011
• Source: Canadian Institute of Natural and Integrative Medicine
• Contact: Sabine Moritz, MSc
• Phone: (403) 220-0022
• Email: s.moritz[@]cinim.org
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (6)

Lead Sponsor	Collaborator
Canadian Institute of Natural and Integrative Medicine	Alberta Children's Hospital, Alberta Health Services, Alberta Heritage Foundation for Medical Research, Lotte & John Hecht Memorial Foundation, SickKids Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.		See primary endpoint	Yes

External Links

•   Canadian Institute of Natural and Integrative Medicine, Calgary