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.
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
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Asthma
Intervention
Orthomolecular Therapy (Vitamins C, E, B6 and B12, magnesium, selenium, quercitin and fish oil)
Location
Alberta Children's Hospital
Calgary
Alberta
Canada
T3B 6A8
Status
Not yet recruiting
Source
Canadian Institute of Natural and Integrative Medicine
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00672529
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Orthomolecular Therapy
The use of very large doses of vitamins or other naturally occurring substances normally present in the body, frequently for the treatment of mental disorders.
Selenious Acid
A selenium compound used as a source of SELENIUM, especially for patients that develop selenium deficiency following prolonged PARENTERAL NUTRITION.
Selenium Radioisotopes
Unstable isotopes of selenium that decay or disintegrate emitting radiation. Se atoms with atomic weights 70-73, 75, 79, 81, and 83-85 are radioactive selenium isotopes.
Selenium-binding Proteins
A group of proteins that covalently attach to selenium or SELENIUM-containing compounds.
Selenium Compounds
Inorganic compounds that contain selenium as an integral part of the molecule.
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