Orthomolecular Therapy and Asthma in Children

Orthomolecular Treatment as add-on Therapy for Childhood Asthma

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Dietary supplement: Orthomolecular Therapy or Placebo Comparator

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sabine Moritz, MSc; Phone Number: 103 (403) 220-0022; Email: s.moritz@cinim.org
• Study Contact Backup: Name: Asthma Trial Coordinator; Phone Number: 106 (403) 220-0022; Email: asthma@cinim.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: CIN-AST-01
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 Names: CIN-AST-01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
The number (percentage) of patients with failed tapering and failed rescue will serve as secondary endpoint.	See primary endpoint

Collaborators and Investigators

• Sponsor: Canadian Institute of Natural and Integrative Medicine
• Collaborators: Alberta Health services; Alberta Children's Hospital; Alberta Heritage Foundation for Medical Research; Lotte & John Hecht Memorial Foundation; SickKids 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

Publications and helpful links

Helpful Links

• Canadian Institute of Natural and Integrative Medicine, Calgary

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: May 5, 2008
• First Submitted That Met QC Criteria: May 5, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): February 4, 2011
• Last Update Submitted That Met QC Criteria: February 2, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Childhood Asthma; Alternative Medicine; Inhaled Corticosteroids; Vitamins, minerals, and fish oil as Add-on Treatment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 18376; NHPD 115797