Orthomolecular Therapy and Asthma in Children

Canadian Institute of Natural and Integrative Medicine

Status and phase: Unknown; Phase 2

Conditions: Asthma

Treatments: Dietary Supplement: Orthomolecular Therapy or Placebo Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT00672529

NHPD 115797

18376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Intervention Group

Active Comparator group

Treatment:

Dietary Supplement: Orthomolecular Therapy or Placebo Comparator

Placebo Group

Placebo Comparator group

Treatment:

Dietary Supplement: Orthomolecular Therapy or Placebo Comparator