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NCT00718796 Clinical Trial

Naturopathic Treatment for the Prevention of Cardiovascular Disease

Cardiovascular Disease Clinical Trial

— Cardio pilot  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00718796
Other study ID # CP/CUPW4
Secondary ID
Status Completed
Phase Phase 3
First received April 25, 2008
Last updated May 14, 2010
Start date April 2008
Est. completion date October 2009

Study information
Verified date May 2010
Source The Canadian College of Naturopathic Medicine
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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.
• Conventional medical treatment (Atorvastatin,Fluvastatin,Lovastatin,Pravastatin,Rosuvastatin,Simvastatin)
Will vary according to individual - not standardized and likely to include statins.

Locations
Country Name City State
Canada Canadian College of Naturopathic Medicine Toronto Ontario

Sponsors (3)
Lead Sponsor Collaborator
The Canadian College of Naturopathic Medicine Canada Post Corporation, Canadian Union of Postal Workers

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Metabolic syndrome 1 year No
Primary General Cardiovascular Risk Profile: Framingham Heart Study 1 year No
Secondary Adverse events 1 year Yes
Secondary HbA1C 1 year No
Secondary Compliance with naturopathic interventions 1 year No
Secondary Quality of Life (Short-form 36) 1 year Yes
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