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OpenTrials
Completed

NCT Number: NCT00718796

Naturopathic Treatment for the Prevention of Cardiovascular Disease

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Canadian College of Naturopathic Medicine

Toronto, Ontario, M2K 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naturopathic medicine. May include: fish oil, plant sterols, soluble fiber, cinnamon, coQ10 and exercise

Other

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

Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)

Other

Will vary according to individual - not standardized and likely to include statins.

Other names: Cholesterol lowering drugs, Atorvastatin, Fluvastatin, Lovastatin, Pravastatin, Rosuvastatin, Simvastatin

Primary outcomes

  1. Metabolic syndrome

    Time frame: 1 year

  2. General Cardiovascular Risk Profile: Framingham Heart Study

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Canadian College of Naturopathic Medicine

Other

Collaborators

  • Canada Post Corporation
  • Canadian Union of Postal Workers

Registry information

Official study title

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

Acronym: Cardio pilot

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 21, 2008
Registry last updated
May 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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