Vitamin D3 + Omega-3 Fatty Acids for Infections

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Cancer, Heart disease, Stroke, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: Ongoing

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily supplements of vitamin D3 or omega-3 fish oil can lower infection risk in individuals without a history of cancer, heart disease, or stroke. Researchers aim to determine if these supplements can improve overall health by reducing illness likelihood. Participants from the original VITAL study can join this trial. Those in VITAL interested in the potential health effects of these supplements may find this trial suitable. As an unphased study, it offers a unique opportunity to contribute to research that could enhance general health and wellness.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to check the main VITAL study details or consult with the trial coordinators for more information.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that vitamin D3 and omega-3 fatty acids are generally safe for use. Studies have found that most people tolerate these supplements well. Side effects of vitamin D3 are usually mild and may include digestive issues or headaches. Omega-3 fatty acids, found in fish oil, can sometimes cause a fishy aftertaste or mild stomach discomfort.

The VITAL study, which examined these supplements in a large group, supports their safety. With many participants involved, any serious side effects would likely have been noticed.

Both vitamin D3 and omega-3 fatty acids have been on the market for a while and are FDA-approved for other uses, adding to their safety record. However, consulting a healthcare provider before starting any new supplement is always important, especially when considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Vitamin D3 and Omega-3 fatty acids for fighting infections because they offer a natural approach to boosting the immune system. Unlike traditional treatments that often rely on antibiotics, which can lead to resistance, these nutrients work by enhancing the body's innate defense mechanisms. Vitamin D3 helps regulate immune responses, while Omega-3 fatty acids, found in fish oil, have anti-inflammatory properties that may reduce infection severity. This combination could provide a safer, complementary option to conventional therapies, potentially reducing reliance on antibiotics.

What evidence suggests that this trial's treatments could be effective for reducing the risk of infection?

This trial will evaluate the effects of vitamin D3 and omega-3 fatty acids on infections. Research has shown that a diet rich in vitamin D and omega-3 fatty acids can reduce inflammation, potentially preventing and treating painful conditions. Studies suggest these supplements could lower infection risk. Vitamin D plays a crucial role in the immune system, helping the body fight infections. Omega-3 fatty acids, found in fish oil, also support immune health and may reduce inflammation. Taking these nutrients together could offer additional benefits for overall health and lower the risk of certain diseases. Participants in this trial will be assigned to different arms, including combinations of vitamin D3, fish oil, and their placebos, to assess their effects on infection risk. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for participants already enrolled in the VITAL study (NCT 01169259), which includes U.S. men and women without a prior history of cancer, heart disease, or stroke.

Inclusion Criteria

Participants in VITAL (NCT 01169259)

Exclusion Criteria

Please see NCT 01169259 for lists of inclusion and exclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily dietary supplements of vitamin D3 or omega-3 fatty acids

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fish Oil
• Vitamin D3

Trial Overview The study tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of infections and affect hCAP18 levels in blood.

How Is the Trial Designed?

Group I: vitamin D placebo + fish oil Active Control 2 Interventions

vitamin D placebo + Omacor

Group II: vitamin D + fish oil Active Control 2 Interventions

vitamin D3 + Omacor

Group III: vitamin D + fish oil placebo Active Control 2 Interventions

vitamin D3 + fish oil placebo

Group IV: vitamin D placebo + fish oil placebo Placebo Group 2 Interventions

vitamin D placebo + fish oil placebo

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37878483/

The effect of vitamin D and omega-3 fatty acid ... - PubMed A diet supplemented with vitamin D and marine omega-3 fatty acids may prevent and treat painful disorders by promoting the resolution of inflammation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01758081

Effects of Vitamin D and Omega-3 Fatty Acids on Infectious ... This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids affect risk of infection and ...

3. clinicaltrial.be clinicaltrial.be/en/details/12528?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Effects of Vitamin D and Omega-3 Fatty Acids on Infectiou... This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids affect risk of ...

4. nature.com nature.com/articles/s43587-024-00793-y

Individual and additive effects of vitamin D, omega-3 and ... Estimates from meta-analyses on the effect of omega-3 fatty acid supplementation on mortality are less comparable to data from DO-HEALTH, as ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9261319/

Combined Vitamin D, Omega-3 Fatty Acids, and a Simple ... Combined vitamin D, Omega-3 fatty acids, and a simple home exercise program may reduce cancer risk among active adults aged 70 and older.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7656284/

Effect of Vitamin D Supplementation, Omega-3 Fatty Acid ... Effect of vitamin D supplementation, Omega-3 fatty acid supplementation, or a strength-training exercise program on clinical outcomes in older adults.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7230517/

Effects of an Omega-3 and Vitamin D Supplement on Fatty ... In vitro models have shown that these fatty acids can have an effect on the tight junctions associated with the gut wall. EPA and DHA were shown ...

8. bmj.com bmj.com/content/376/bmj-2021-066452

Vitamin D and marine omega 3 fatty acid supplementation ... A Danish observational study found a 49% reduction in rheumatoid arthritis risk for each 30 g increase in daily fatty fish intake (≥8 g fat/100 ...