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Trial record 15 of 593 for:
diabetes type 2 AND (woman OR women OR female)
Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes
This study is ongoing, but not recruiting participants.
Sponsor:
Brigham and Women's Hospital
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yiqing Song, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01633177
First received: June 26, 2012
Last updated: June 2, 2014
Last verified: June 2014
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Purpose
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among nondiabetic participants in VITAL and will examine whether vitamin D or fish oil prevent type 2 diabetes. Findings from this proposed study conducted within the VITAL trial will clarify whether vitamin D and omega-3 fatty acid supplementation reduces risk of type 2 diabetes and thus will inform public health and clinical guidelines for diabetes prevention.
| Condition | Intervention |
|---|---|
| Type 2 Diabetes | Dietary Supplement: Vitamin D3 Drug: Omega-3 fatty acid (fish oil) Dietary Supplement: Vitamin D3 placebo Drug: Fish oil placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Diabetes Prevention in the Vitamin D and Omega-3 Trial |
Resource links provided by NLM:
Further study details as provided by Yiqing Song, Brigham and Women's Hospital:
Primary Outcome Measures:
- Incident type 2 diabetes [ Time Frame: 5 years ]
Secondary Outcome Measures:
- OGTT index of insulin sensitivity [ Time Frame: 2 years ]
- OGTT index of beta-cell function [ Time Frame: 2 years ]
- HbA1c levels [ Time Frame: 2 years ]
| Enrollment: | 25875 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Vitamin D and Omega-3 |
Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol
Drug: Omega-3 fatty acid (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
Other Names:
|
| Active Comparator: Vitamin D and Omega-3 placebo |
Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol
Drug: Fish oil placebo
Fish oil placebo
|
| Active Comparator: Vitamin D placebo and Omega-3 |
Drug: Omega-3 fatty acid (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
Other Names:
Dietary Supplement: Vitamin D3 placebo
Vitamin D3 placebo
|
| Placebo Comparator: Vitamin D placebo and Omega-3 placebo |
Dietary Supplement: Vitamin D3 placebo
Vitamin D3 placebo
Drug: Fish oil placebo
Fish oil placebo
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Participants in VITAL (NCT01169259) who have no history of diabetes mellitus at baseline are eligible to participate in this ancillary study.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633177
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633177
Locations
| United States, Massachusetts | |
| Division of Preventive Medicine, Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | Yiqing Song, MD, ScD | Brigham and Women's Hospital |
More Information
| Responsible Party: | Yiqing Song, Assistant Professor of Medicine, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01633177 History of Changes |
| Other Study ID Numbers: |
0308112690000 R01DK088078 ( U.S. NIH Grant/Contract ) |
| Study First Received: | June 26, 2012 |
| Last Updated: | June 2, 2014 |
Keywords provided by Yiqing Song, Brigham and Women's Hospital:
|
vitamin D omega-3 fatty acids Type 2 diabetes |
Oral glucose tolerance test (OGTT) Insulin sensitivity Beta-cell function |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vitamins Vitamin D |
Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on July 21, 2017