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Fatty Acid

Vitamin D + Omega-3 for Diabetes Prevention

N/A

Waitlist Available

Led By Yiqing Song, MD, ScD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants in VITAL (NCT01169259) who have no history of diabetes mellitus at baseline are eligible to participate in this ancillary study

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing whether taking daily supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

Who is the study for?

This trial is for men and women already participating in the VITAL study without a history of diabetes. It aims to see if taking daily supplements of vitamin D3 or omega-3 fatty acids can prevent type 2 diabetes in those who don't have it.Check my eligibility

What is being tested?

The trial tests whether daily doses of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can lower the risk of developing type 2 diabetes among participants with no prior instances of heart disease, cancer, or stroke.See study design

What are the potential side effects?

Potential side effects from Vitamin D supplementation may include nausea, constipation, and weakness. Omega-3s might cause a fishy aftertaste, upset stomach, and bleeding risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incident type 2 diabetes

Secondary outcome measures

HbA1c levels

OGTT index of beta-cell function

OGTT index of insulin sensitivity

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D and Omega-3Active Control2 Interventions

Group II: Vitamin D and Omega-3 placeboActive Control2 Interventions

Group III: Vitamin D placebo and Omega-3Active Control2 Interventions

Group IV: Vitamin D placebo and Omega-3 placeboPlacebo Group2 Interventions

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,618 Previous Clinical Trials

11,445,835 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,364 Previous Clinical Trials

4,289,527 Total Patients Enrolled

Yiqing Song, MD, ScDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Fish Oil Placebo (Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT01633177 — N/A

Type 2 Diabetes Research Study Groups: Vitamin D and Omega-3, Vitamin D and Omega-3 placebo, Vitamin D placebo and Omega-3, Vitamin D placebo and Omega-3 placebo

Type 2 Diabetes Clinical Trial 2023: Fish Oil Placebo Highlights & Side Effects. Trial Name: NCT01633177 — N/A

Fish Oil Placebo (Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01633177 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any previous studies that have explored the effects of Vitamin D and Omega-3 combining?

"Currently, 21 medical studies are underway that involve Vitamin d and Omega-3 with 7 trials in their final stage. Although the majority of these clinical trails are based in Boston, Massachusetts there is a total of 52 locations offering research on this topic."

Answered by AI

Is this trial pioneering a novel approach to treatment?

"Since its inception in 2005, Vitamin d and Omega-3 has been extensively studied. Supported by Bayer's initial trial involving 15480 participants, the duo have since achieved Phase 4 drug approval. Presently, 21 ongoing studies are located across 11 cities and 10 nations worldwide."

Answered by AI

Is this experiment actively seeking participants?

"This research endeavour is no longer recruiting patients, according to the information on clinicaltrials.gov. The study was initially posted on September 1st 2010 and revised for the last time on May 30th 2023; however, there are still 1461 other trials actively looking for participants."

Answered by AI

How many participants has this trial recruited so far?

"This research endeavour is not presently taking on new recruits. The experiment was initially published on September 1st 2010 and has since been amended as of May 30th 2023. If you're exploring alternative clinical trials, there are 1440 type 2 diabetes studies currently seeking participants and 21 Vitamin d/ Omega-3 investigations actively enrolling patients."

Answered by AI

What maladies are Vitamin D and Omega-3 commonly prescribed to address?

"Type III Hyperlipidaemia is typically managed through Vitamin d and Omega-3 supplementation. This remedy has also been effective at tackling inadequate triglyceride control, failure to respond to dieting, and other conditions related to lipid levels."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes

Aruna Das Pradhan, MD 2010. "Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01633177.

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