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Cardio pilot: Naturopathic Treatment for the Prevention of Cardiovascular Disease

Sponsor
The Canadian College of Naturopathic Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00718796
Collaborator
Canada Post Corporation (Other), Canadian Union of Postal Workers (Other)
300
Enrollment
1
Location
2
Arms
18
Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to test the ability of a comprehensive naturopathic approach to reduce important risk factors for the development of cardiovascular disease. Treatment will take place over the course of one year and the comparator/control group will be followed by their medical doctors and be given conventional care.

Condition or Disease Intervention/Treatment Phase
  • Other: Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise
  • Other: Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)
 Phase 3

Detailed Description

Interventions will consist of an individualized treatment approach guided by an expert panel of clinicians who treat patients with cardiovascular disease. These interventions will consist of a combination of dietary, lifestyle and specific recommendations for supplementation. As this is a pragmatic study, blinding will not be attempted nor is appropriate.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Individualized naturopathic treatment consisting of dietary and lifestyle advice and individualized supplementation

Other: Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise
Individualized according to needs of each participant and willingness to comply. Intervention to include lifestyle modification, dietary changes and supplementation using natural health products as recommended by naturopathic practitioner.
Other Names:
  • Naturopthic Medicine
  • Diet
  • Natural Health Products
  • Alternative Medicine
  • Fish oil
  • Plant sterols
  • Soluble fiber
  • CoQ10
  • Cinnamon
  • Exercise

    		•
    Active Comparator: 2

    Current care control provided by participants' medical doctor

    Other: Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)
    Will vary according to individual - not standardized and likely to include statins.
    Other Names:
  • Cholesterol lowering drugs
  • Atorvastatin
  • Fluvastatin
  • Lovastatin
  • Pravastatin
  • Rosuvastatin
  • Simvastatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Metabolic syndrome [1 year]

    2. General Cardiovascular Risk Profile: Framingham Heart Study [1 year]

    Secondary Outcome Measures

    1. Adverse events [1 year]

    2. HbA1C [1 year]

    3. Compliance with naturopathic interventions [1 year]

    4. Quality of Life (Short-form 36) [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 to 65 years old

    • CUPW worker

    • prescreening indicates higher than normal TC/HDL ratio

    Exclusion Criteria:
    • Experienced an MI or stroke within past 6 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Canadian College of Naturopathic Medicine Toronto Ontario Canada M2K 1E2

    Sponsors and Collaborators

    • The Canadian College of Naturopathic Medicine
    • Canada Post Corporation
    • Canadian Union of Postal Workers

    Investigators

    • Principal Investigator: Dugald Seely, ND, Canadian College of Naturopathic Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00718796
    Other Study ID Numbers:
    • CP/CUPW4
    First Posted:
    Jul 21, 2008
    Last Update Posted:
    May 17, 2010
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    cardiovascular disease
    naturopathic medicine
    natural health products
    lifestyle intervention
    dietary advice
    coronary heart disease
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Coenzyme Q10
    Ubiquinone
    Atorvastatin
    Rosuvastatin Calcium
    Simvastatin
    Pravastatin
    Lovastatin
    L 647318
    Dihydromevinolin
    Anticholesteremic Agents

    Study Results

    No Results Posted as of May 17, 2010