Naturopathic Treatment for the Prevention of Cardiovascular Disease

NCT ID: NCT00718796

Last Updated: 2010-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Individualized naturopathic treatment consisting of dietary and lifestyle advice and individualized supplementation

Group Type EXPERIMENTAL

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

Intervention Type 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.

2

Current care control provided by participants' medical doctor

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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

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

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canada Post Corporation

UNKNOWN

Sponsor Role collaborator

Canadian Union of Postal Workers

OTHER

Sponsor Role collaborator

The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Canadian College of Naturopathic Medicine

Principal Investigators

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Dugald Seely, ND

Role: PRINCIPAL_INVESTIGATOR

Canadian College of Naturopathic Medicine

Locations

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Canadian College of Naturopathic Medicine

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Herman PM, Szczurko O, Cooley K, Seely D. A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial. J Occup Environ Med. 2014 Feb;56(2):171-6. doi: 10.1097/JOM.0000000000000066.

Reference Type DERIVED
PMID: 24451612 (View on PubMed)

Seely D, Szczurko O, Cooley K, Fritz H, Aberdour S, Herrington C, Herman P, Rouchotas P, Lescheid D, Bradley R, Gignac T, Bernhardt B, Zhou Q, Guyatt G. Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial. CMAJ. 2013 Jun 11;185(9):E409-16. doi: 10.1503/cmaj.120567. Epub 2013 Apr 29.

Reference Type DERIVED
PMID: 23630244 (View on PubMed)

Related Links

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http://www.ccnm.edu

Central facility website

Other Identifiers

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CP/CUPW4

Identifier Type: -

Identifier Source: org_study_id

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