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

This study has been completed.
Sponsor:
Collaborators:
Canada Post Corporation
Canadian Union of Postal Workers
Information provided by:
The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT00718796
First received: April 25, 2008
Last updated: May 14, 2010
Last verified: May 2010
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:
  • Metabolic syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • General Cardiovascular Risk Profile: Framingham Heart Study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • HbA1C [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Compliance with naturopathic interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of Life (Short-form 36) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718796

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

Additional Information:
Central facility website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dugald Seely, Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00718796     History of Changes
Other Study ID Numbers: CP/CUPW4
Study First Received: April 25, 2008
Last Updated: May 14, 2010
Health Authority: Canada: Health Canada

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:
Cardiovascular Diseases
Anticholesteremic Agents
Lovastatin
Simvastatin
Atorvastatin
Fluvastatin
Pravastatin
Rosuvastatin
Coenzyme Q10
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013