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

May 14, 2010 updated by: The Canadian College of Naturopathic Medicine

Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M2K 1E2
        • Canadian College of Naturopathic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Exercise
  • Diet
  • Fish oil
  • CoQ10
  • Cinnamon
  • Naturopthic Medicine
  • Natural Health Products
  • Alternative Medicine
  • Plant sterols
  • Soluble fiber
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:
  • Rosuvastatin
  • Atorvastatin
  • Simvastatin
  • Pravastatin
  • Fluvastatin
  • Cholesterol lowering drugs
  • Lovastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic syndrome
Time Frame: 1 year
1 year
General Cardiovascular Risk Profile: Framingham Heart Study
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 1 year
1 year
HbA1C
Time Frame: 1 year
1 year
Compliance with naturopathic interventions
Time Frame: 1 year
1 year
Quality of Life (Short-form 36)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Canadian College of Naturopathic Medicine

Collaborators

Canada Post Corporation
Canadian Union of Postal Workers

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

May 17, 2010

Last Update Submitted That Met QC Criteria

May 14, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP/CUPW4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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