Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 25, 2008
First Posted Date  ICMJE July 21, 2008
Last Update Posted Date May 17, 2010
Study Start Date  ICMJE April 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
  • Metabolic syndrome [ Time Frame: 1 year ]
  • General Cardiovascular Risk Profile: Framingham Heart Study [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
TC/HDL - cholesterol ratio [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
  • Adverse events [ Time Frame: 1 year ]
  • HbA1C [ Time Frame: 1 year ]
  • Compliance with naturopathic interventions [ Time Frame: 1 year ]
  • Quality of Life (Short-form 36) [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2008)
  • Adverse events [ Time Frame: 1 year ]
  • HbA1C [ Time Frame: 1 year ]
  • Compliance with naturopathic interventions [ Time Frame: 1 year ]
  • 10 year risk of cardiovascular disease [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Naturopathic Treatment for the Prevention of Cardiovascular Disease
Official Title  ICMJE Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Individualized naturopathic treatment consisting of dietary and lifestyle advice and individualized supplementation
    Intervention: Other: Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise
  • Active Comparator: 2
    Current care control provided by participants' medical doctor
    Intervention: Other: Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 18, 2008)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00718796
Other Study ID Numbers  ICMJE CP/CUPW4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dugald Seely, Canadian College of Naturopathic Medicine
Study Sponsor  ICMJE The Canadian College of Naturopathic Medicine
Collaborators  ICMJE
  • Canada Post Corporation
  • Canadian Union of Postal Workers
Investigators  ICMJE
Principal Investigator: Dugald Seely, ND Canadian College of Naturopathic Medicine
PRS Account The Canadian College of Naturopathic Medicine
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP