Type 2 Diabetes MellitusPhase 3NCT01326442
Vitamin D and Omega-3 Inhibit Metabolic Syndrome
A Phase 3 study testing low glycemic diet and vitamin D omega-3 in people with Type 2 Diabetes Mellitus and Hypertension, run by University of Guelph at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension, Hyperlipidemia
- What is being tested?
- low glycemic diet and vitamin D omega-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant or lactating
- vegetarian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus, Hypertension, Hyperlipidemia, Obesity
- Being tested
- low glycemic diet, vitamin D omega-3
- Keywords
- weight loss, overweight, body composition, visceral obesity, insulin, glucose tolerance, cholesterol, hypertriglyceridemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Hyperlipidemias, Obesity, Weight Loss, Overweight, Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low glycemic dietOther
a low glycemic diet, calorie restricted with exercise sessions 3 times per week
vitamin D omega-3Dietary supplement
2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| diet only | Experimental | low glycemic index diet, calorie restricted with exercise 3 times per week. Receives: Other: low glycemic diet |
| supplemented | Active comparator | 2000 IU vitamin D3 plus 1.8 g EPA + DHA Receives: Other: low glycemic diet; Dietary Supplement: vitamin D omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight will be measured to nearest 0.5 kg weekly
Measured: up to 16 weeks
Secondary outcomes (3)
Blood pressure
systolic and diastolic blood pressure will be measured in duplicate, weekly
Measured: up to 16 weeks
Blood lipids
blood lipids will be measured at baseline and after study completion.
Measured: up to 16 weeks
Glucose homeostasis
fasting blood glucose, insulin, HbA1c, CRP, cytokines and inflammatory markers will be measured at weeks 0 and 16 of the intervention.
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Anne Meckling, PhD, University of Guelph
- Investigators
- Kelly A Meckling, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326442
- Sponsor's protocol ID
- 2011MeckVitD
- Status last verified
- Jun 2013
- First submitted
- 29 Mar 2011
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01326442
- Acronym / sponsor ID
- 2011MeckVitD
- Conditions
- Type 2 Diabetes Mellitus, Hypertension, Hyperlipidemia, Obesity
- Keywords
- weight loss, overweight, body composition, visceral obesity, insulin, glucose tolerance, cholesterol, hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diet only | Experimental | Other: low glycemic dietlow glycemic index diet, calorie restricted with exercise 3 times per week. |
| supplemented | Active comparator | Other: low glycemic diet, Dietary Supplement: vitamin D omega-32000 IU vitamin D3 plus 1.8 g EPA + DHA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- pregnant or lactating
- vegetarian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low glycemic dieta low glycemic diet, calorie restricted with exercise sessions 3 times per week | Other | diet only, supplemented |
| vitamin D omega-32000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks. | Dietary supplement | supplemented |
Primary outcome
body weight
Time frame: up to 16 weeks
body weight will be measured to nearest 0.5 kg weekly
3 secondary outcomes
Blood pressure
Time frame: up to 16 weeks
Blood lipids
Time frame: up to 16 weeks
Glucose homeostasis
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly A Meckling, PhD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing low glycemic diet and vitamin D omega-3 in people with Type 2 Diabetes Mellitus and Hypertension, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.