Recruiting
Phase 2

Orthomolecular Therapy

Sponsor:

Canadian Institute of Natural and Integrative Medicine

Code:

NCT00672529

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Interventions

Orthomolecular Therapy or Placebo Comparator

Study Details

Brief 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

Study ID

NCT00672529

Start date

Feb, 2011

Status verified date

Feb, 2011

Completion date

Mar, 2013

Anticipated

Primary completion date

Mar, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention Group

placebo comparator: Placebo Group

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Sabine Moritz, MSc

(403) 220-0022s.moritz@cinim.org

Asthma Trial Coordinator

(403) 220-0022asthma@cinim.org

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Principal Investigator:

Sheldon Spier

More Information

Sponsor

Canadian Institute of Natural and Integrative Medicine

Last update posted

Feb 4, 2011

Last verified

Feb, 2011

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Institute of Natural and Integrative Medicine on 2011-02-04.