We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Vitamin D and Omega-3 Inhibit Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01326442
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : June 13, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypertension Hyperlipidemia Obesity Other: low glycemic diet Dietary Supplement: vitamin D omega-3 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome
Study Start Date : April 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Arms and Interventions

Arm Intervention/treatment
Experimental: diet only
low glycemic index diet, calorie restricted with exercise 3 times per week.
Other: low glycemic diet
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
Other: low glycemic diet
a low glycemic diet, calorie restricted with exercise sessions 3 times per week
Dietary Supplement: vitamin D omega-3
2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.

Outcome Measures

Primary Outcome Measures :
  1. body weight [ Time Frame: up to 16 weeks ]
    body weight will be measured to nearest 0.5 kg weekly

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: up to 16 weeks ]
    systolic and diastolic blood pressure will be measured in duplicate, weekly

  2. Blood lipids [ Time Frame: up to 16 weeks ]
    blood lipids will be measured at baseline and after study completion.

  3. 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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326442

Canada, Ontario
University of Guelph
Guelph, Ontario, Canada, N1G2W1
Sponsors and Collaborators
University of Guelph
Principal Investigator: Kelly A Meckling, PhD University of Guelph
More Information

Responsible Party: Kelly Anne Meckling, PhD, Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT01326442     History of Changes
Other Study ID Numbers: 2011MeckVitD
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by Kelly Anne Meckling, PhD, University of Guelph:
weight loss
body composition
visceral obesity
glucose tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Lipid Metabolism Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents