Naturopathic Treatment for the Prevention of Cardiovascular Disease
Cardio pilot
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedMay 17, 2010
May 1, 2010
1.5 years
April 25, 2008
May 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Metabolic syndrome
1 year
General Cardiovascular Risk Profile: Framingham Heart Study
1 year
Secondary Outcomes (4)
Adverse events
1 year
HbA1C
1 year
Compliance with naturopathic interventions
1 year
Quality of Life (Short-form 36)
1 year
Study Arms (2)
1
EXPERIMENTALIndividualized naturopathic treatment consisting of dietary and lifestyle advice and individualized supplementation
2
ACTIVE COMPARATORCurrent care control provided by participants' medical doctor
Interventions
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.
Will vary according to individual - not standardized and likely to include statins.
Eligibility Criteria
You may qualify if:
- to 65 years old
- CUPW worker
- prescreening indicates higher than normal TC/HDL ratio
You may not qualify if:
- Experienced an MI or stroke within past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Canadian College of Naturopathic Medicinelead
- Canada Post Corporationcollaborator
- Canadian Union of Postal Workerscollaborator
Study Sites (1)
Canadian College of Naturopathic Medicine
Toronto, Ontario, M2K 1E2, Canada
Related Publications (2)
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.
PMID: 24451612DERIVEDSeely 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.
PMID: 23630244DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dugald Seely, ND
Canadian College of Naturopathic Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 25, 2008
First Posted
July 21, 2008
Study Start
April 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
May 17, 2010
Record last verified: 2010-05