Vitamin D + Omega-3 for Preventing Major Diseases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether daily supplements of vitamin D3 or omega-3 fish oil can prevent cancer, heart disease, and stroke in individuals without these illnesses. Researchers also aim to determine if vitamin D reduces bone fractures. Participants will be divided into groups to take either the supplements or placebos (inactive substances). Those already in the VITAL study, who have not experienced cancer, heart disease, or a stroke, might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could lead to new preventive health strategies.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both vitamin D3 and fish oil are generally safe at the studied doses. Vitamin D3 is safe in appropriate amounts, but excessive intake can be harmful. Fish oil, containing omega-3 fatty acids, is also well-tolerated. Studies suggest that up to 3 grams per day is safe with minimal health risks, and most people experience no serious side effects. No interactions have been found when vitamin D3 and fish oil are taken together, indicating they are safe to use in combination. However, consulting a healthcare provider before starting any supplement is advisable, especially if other medications are being taken.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the potential of fish oil and vitamin D in preventing major diseases because they bring a natural approach to health that differs from conventional treatments. Fish oil is rich in omega-3 fatty acids, which are believed to support heart health and reduce inflammation. Meanwhile, vitamin D plays a crucial role in bone health and immune function. Unlike standard medications that often target specific symptoms or conditions, these nutrients aim to bolster overall health and potentially ward off a range of diseases before they develop. This proactive, preventative strategy is what makes these treatments particularly intriguing.
What evidence suggests that this trial's treatments could be effective for preventing major diseases?
This trial will evaluate the effects of Vitamin D and fish oil, both separately and in combination, on preventing major diseases. Research has shown that fish oil might help lower the risk of heart disease and stroke. Some studies suggest it can reduce the chances of dying from heart problems and sudden heart-related events. However, not all research agrees, and some studies find no significant effect on overall heart disease risk. Vitamin D supports bone health by aiding calcium absorption, but its role in preventing cancer or heart disease remains unclear. Some research indicates that vitamin D might reduce the risk of fractures, but more evidence is needed to confirm its role in preventing major diseases. Together, vitamin D and fish oil might help slow aging, but they don't have a strong impact on preventing heart attacks or cancer. Participants in this trial will be assigned to one of four groups: Vitamin D with fish oil, Vitamin D with fish oil placebo, Vitamin D placebo with fish oil, or both placebos.678910
Who Is on the Research Team?
Meryl S LeBoff, M.D.
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for U.S. men and women who were part of the VITAL parent study, looking at whether daily supplements of vitamin D3 or omega-3 fatty acids can prevent cancer, heart disease, and stroke in those without a history of these conditions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) to assess their impact on fracture risk
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on incident total, non-vertebral, and hip fractures
What Are the Treatments Tested in This Trial?
Interventions
- Fish Oil
- Vitamin D3
Trial Overview
The study tests if taking vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram) daily reduces the risk of broken bones. It also explores if vitamin D's effect on bone fractures is influenced by genetic factors related to vitamin D levels.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Citations
Omega-3s for heart health? Exploring potential benefits ...
Taking 1 gram of omega-3 supplements daily did not significantly lower the overall risk of major cardiovascular disease (CVD) events.
Regular use of fish oil supplements and course ...
The protective effect of regular use of fish oil supplements on the transition from healthy states to death was greater in men (hazard ratio 0.93, 95% CI 0.89 ...
n−3 Fatty acids from fish or fish-oil supplements, but not α- ...
Most trials reported that fish oil significantly reduced all-cause mortality, myocardial infarction, cardiac and sudden death, or stroke.
Effect of omega-3 fatty acids on cardiovascular outcomes
Omega-3 FAs reduced cardiovascular mortality and improved cardiovascular outcomes. The cardiovascular risk reduction was more prominent with EPA monotherapy ...
5.
bmcpublichealth.biomedcentral.com
bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-19512-8Associations of fish oil with cardiovascular disease events
Some studies indicate a correlation between the use of fish oil supplements and reduced mortality or decreased incidence of stroke. However, ...
fish oils
This mixture has not been evaluated as a whole for health effects. Information provided on health effects of this product is based on the individual ...
Safety Data Sheet Omega-3 Fatty Acids - Redox
- Eye/face protection: Wear appropriate eye protection to avoid eye contact, e.g. Safety glasses. - Hand protection: Handle with gloves.
3275 SRM Name: Omega-3 and Omega-6 Fatty Acids in Fis
Description: This SRM is intended primarily for validation of methods for determining fatty acids in fish oils and similar materials. This SRM ...
9.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9PHRVI_OMEGA_3_FISH_OIL_SGEL_MINI_60_CT.pdfMSDS EPAZoo Omega-3 Liquid
WASTE DISPOSAL METHOD: Clean all spills immediately, Spills from fats and oils produce slippery surfaces. If large spill contain and absorb spill with sand ...
10.
spectrumchemical.com
spectrumchemical.com/MSDS/F1192_AGHS.pdf?srsltid=AfmBOoprexhOJDq0XvTaUoVE8JPC2xlM0o12ewWrdg8X1eyBzWrg-J1xSAFETY DATA SHEET
Hazardous combustion products. Carbon Monoxide, Carbon Dioxide. Explosion data. Sensitivity to mechanical impact none. Sensitivity to static ...
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