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

This study has been completed.

Sponsor:

Collaborators:

Canada Post Corporation

Canadian Union of Postal Workers

Information provided by:

The Canadian College of Naturopathic Medicine

ClinicalTrials.gov Identifier:

NCT00718796

First received: April 25, 2008

Last updated: May 14, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

May 14, 2010

Start Date ^ICMJE

April 2008

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Metabolic syndrome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
General Cardiovascular Risk Profile: Framingham Heart Study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

TC/HDL - cholesterol ratio [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00718796 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
HbA1C [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Compliance with naturopathic interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of Life (Short-form 36) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
HbA1C [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Compliance with naturopathic interventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
10 year risk of cardiovascular disease [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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 *

Not Provided

* 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

300

Completion Date

October 2009

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00718796

Other Study ID Numbers ^ICMJE

CP/CUPW4

Has Data Monitoring Committee

Yes

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

Information Provided By

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

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