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Naturopathic Treatment for the Prevention of Cardiovascular Disease (Cardio pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00718796
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : May 17, 2010
Sponsor:
Collaborators:
Canada Post Corporation
Canadian Union of Postal Workers
Information provided by:
The Canadian College of Naturopathic Medicine

Study Description
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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
Cardiovascular Disease 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Metabolic syndrome [ Time Frame: 1 year ]
  2. General Cardiovascular Risk Profile: Framingham Heart Study [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 1 year ]
  2. HbA1C [ Time Frame: 1 year ]
  3. Compliance with naturopathic interventions [ Time Frame: 1 year ]
  4. Quality of Life (Short-form 36) [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718796


Locations
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Canada, Ontario
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
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Principal Investigator: Dugald Seely, ND Canadian College of Naturopathic Medicine
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dugald Seely, Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00718796    
Other Study ID Numbers: CP/CUPW4
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: May 17, 2010
Last Verified: May 2010
Keywords provided by The Canadian College of Naturopathic Medicine:
cardiovascular disease
naturopathic medicine
natural health products
 lifestyle intervention
dietary advice
coronary heart disease
Additional relevant MeSH terms:
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Cardiovascular Diseases
Coenzyme Q10
Ubiquinone
Atorvastatin
Rosuvastatin Calcium
Simvastatin
Pravastatin
Lovastatin
L 647318
Dihydromevinolin
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vitamins
Micronutrients
Physiological Effects of Drugs