Orthomolecular Therapy and Asthma in Children

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.

Conditions

• Asthma

Interventions

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.

Sponsors & Collaborators

• Alberta Children's Hospital

  collaborator OTHER

• Alberta Health services

  collaborator OTHER

• Alberta Heritage Foundation for Medical Research

  collaborator OTHER

• SickKids Foundation

  collaborator OTHER

• Lotte & John Hecht Memorial Foundation

  collaborator OTHER

• Canadian Institute of Natural and Integrative Medicine

  lead OTHER

Principal Investigators

• Sabine Moritz, MSc · Canadian Institute of Natural and Integrative Medicine

• Badri Rickhi, MB,BS,FRCPC · Canadian Institute of Natural and Integrative Medicine

• Hude Quan, MD, PhD · University of Calgary

• Sheldon Spier, MD,CM,FRCPC · Alberta Children's Hospital

• Mary Noseworthy, MD, FRCPC · Alberta Children's Hospital

• Eric Arrata, ND · Paradigm Health Group

• Trevor Hoffman, ND · Paradigm Health Group

• Paul Saunders, PhD, ND · Canadian College of Naturopathic Medicine

• Sunita Vohra, MD,FRCPC,MSc · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• Canada

Study Locations