Vitamin D and Omega-3 Inhibit Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kelly Anne Meckling, PhD, University of Guelph
ClinicalTrials.gov Identifier:
NCT01326442
First received: March 29, 2011
Last updated: June 12, 2013
Last verified: June 2013

March 29, 2011
June 12, 2013
April 2011
December 2012   (final data collection date for primary outcome measure)
body weight [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    systolic and diastolic blood pressure will be measured in duplicate, weekly
  • Blood lipids [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    blood lipids will be measured at baseline and after study completion.
  • Glucose homeostasis [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • 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.
 
Completed
40
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01326442
2011MeckVitD
Yes
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