Vitamin D and Omega-3 Inhibit Metabolic Syndrome

Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01326442

Enrollment

Registered

2011-03-30

Start date

2011-04-30

Completion date

2012-12-31

Last updated

2013-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Hypertension, Obesity, Type 2 Diabetes Mellitus

Keywords

weight loss, overweight, body composition, visceral obesity, insulin, glucose tolerance, cholesterol, hypertriglyceridemia

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.

Interventions

OTHERlow glycemic diet

a low glycemic diet, calorie restricted with exercise sessions 3 times per week

DIETARY_SUPPLEMENTvitamin D omega-3

2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
body weight	up to 16 weeks	body weight will be measured to nearest 0.5 kg weekly

Secondary

Measure	Time frame	Description
Blood pressure	up to 16 weeks	systolic and diastolic blood pressure will be measured in duplicate, weekly
Blood lipids	up to 16 weeks	blood lipids will be measured at baseline and after study completion.
Glucose homeostasis	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026