Orthomolecular Therapy and Asthma in Children - Full Text View

Purpose

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.

Condition	Intervention	Phase
Asthma	Dietary Supplement: Orthomolecular Therapy or Placebo Comparator	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Orthomolecular Treatment as add-on Therapy for Childhood Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids

U.S. FDA Resources

Further study details as provided by Canadian Institute of Natural and Integrative Medicine:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint. [ Time Frame: See primary endpoint ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	February 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intervention Group	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. Other Name: CIN-AST-01
Placebo Comparator: Placebo Group	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. Other Name: CIN-AST-01

Arms

Assigned Interventions

Active Comparator: Intervention Group

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.

Other Name: CIN-AST-01

Placebo Comparator: Placebo Group

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.

Other Name: CIN-AST-01

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.

Eligibility

Ages Eligible for Study:	7 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672529

Contacts

Contact: Sabine Moritz, MSc	(403) 220-0022 ext 103	s.moritz@cinim.org
Contact: Asthma Trial Coordinator	(403) 220-0022 ext 106	asthma@cinim.org

Locations

Canada, Alberta
Alberta Children's Hospital	Recruiting
Calgary, Alberta, Canada, T3B 6A8
Principal Investigator: Sheldon Spier

Sponsors and Collaborators

Canadian Institute of Natural and Integrative Medicine

Alberta Children's Hospital

Alberta Health Services

Alberta Heritage Foundation for Medical Research

SickKids Foundation

Lotte & John Hecht Memorial Foundation

Investigators

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

More Information

Additional Information:

Canadian Institute of Natural and Integrative Medicine, Calgary This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sabine Moritz, Director of Research, Canadian Institute of Natural and Integrative Medicine
ClinicalTrials.gov Identifier:	NCT00672529 History of Changes
Other Study ID Numbers:	18376, NHPD 115797
Study First Received:	May 5, 2008
Last Updated:	February 2, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Canadian Institute of Natural and Integrative Medicine:

Childhood Asthma
Inhaled Corticosteroids
Alternative Medicine
Vitamins, minerals, and fish oil as Add-on Treatment

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013