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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):

March 29, 2011
March 30, 2011
June 13, 2013
April 2011
December 2012   (Final data collection date for primary outcome measure)
body weight [ Time Frame: up to 16 weeks ]
body weight will be measured to nearest 0.5 kg weekly
Same as current
Complete list of historical versions of study NCT01326442 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: up to 16 weeks ]
    systolic and diastolic blood pressure will be measured in duplicate, weekly
  • Blood lipids [ Time Frame: up to 16 weeks ]
    blood lipids will be measured at baseline and after study completion.
  • 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.
Same as current
Not Provided
Not Provided
Vitamin D and Omega-3 Inhibit Metabolic Syndrome
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Hypertension
  • Hyperlipidemia
  • Obesity
  • 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.
  • Experimental: diet only
    low glycemic index diet, calorie restricted with exercise 3 times per week.
    Intervention: Other: low glycemic diet
  • Active Comparator: supplemented
    2000 IU vitamin D3 plus 1.8 g EPA + DHA
    • Other: low glycemic diet
    • Dietary Supplement: vitamin D omega-3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Kelly Anne Meckling, PhD, University of Guelph
University of Guelph
Not Provided
Principal Investigator: Kelly A Meckling, PhD University of Guelph
University of Guelph
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP