- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01326442
Vitamin D and Omega-3 Inhibit Metabolic Syndrome
June 12, 2013 updated by: Kelly Anne Meckling, PhD, University of Guelph
Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome
The study will test the hypothesis that supplementing the diet of subjects with Metabolic Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will facilitate weight loss, improve body composition and reduce metabolic and biochemical risk factors associated with type II diabetes and cardiovascular disease.
Adult men and women who meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled and embark on a 16 week diet and exercise intervention using a low glycemic index diet with or without the supplementary vitamin D and omega-3.
Subjects will be counseled weekly and blood collected at weeks 0 and 16.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G2W1
- University of Guelph
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must have Metabolic Syndrome as defined by International Diabetes Federation
- must be able to swallow tablets and capsules
- must be 18 years of age or older
- must be physically capable of moderate intensity exercise
Exclusion Criteria:
- pregnant or lactating
- vegetarian
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: diet only
low glycemic index diet, calorie restricted with exercise 3 times per week.
|
a low glycemic diet, calorie restricted with exercise sessions 3 times per week
|
Active Comparator: supplemented
2000 IU vitamin D3 plus 1.8 g EPA + DHA
|
a low glycemic diet, calorie restricted with exercise sessions 3 times per week
2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body weight
Time Frame: up to 16 weeks
|
body weight will be measured to nearest 0.5 kg weekly
|
up to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: up to 16 weeks
|
systolic and diastolic blood pressure will be measured in duplicate, weekly
|
up to 16 weeks
|
Blood lipids
Time Frame: up to 16 weeks
|
blood lipids will be measured at baseline and after study completion.
|
up to 16 weeks
|
Glucose homeostasis
Time Frame: up to 16 weeks
|
fasting blood glucose, insulin, HbA1c, CRP, cytokines and inflammatory markers will be measured at weeks 0 and 16 of the intervention.
|
up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kelly A Meckling, PhD, University of Guelph
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 29, 2011
First Submitted That Met QC Criteria
March 29, 2011
First Posted (Estimate)
March 30, 2011
Study Record Updates
Last Update Posted (Estimate)
June 13, 2013
Last Update Submitted That Met QC Criteria
June 12, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Insulin Resistance
- Hyperinsulinism
- Lipid Metabolism Disorders
- Dyslipidemias
- Diabetes Mellitus, Type 2
- Metabolic Syndrome
- Hyperlipidemias
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Vitamin D
Other Study ID Numbers
- 2011MeckVitD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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