Vitamin D + Fish Oil for Health Improvement

(VITAL Trial)

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether daily supplements of vitamin D or fish oil can reduce the risk of cancer, heart disease, and stroke. It also investigates the effects of these supplements on autoimmune diseases, inflammation markers (which indicate the body's response to threats), and chronic knee pain. Researchers will track participants with regular, ongoing knee pain to observe any changes with the supplements. Individuals with frequent knee pain and no history of cancer, heart disease, or stroke may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding the broader health benefits of these supplements.

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 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 D and fish oil are generally safe when taken in recommended amounts. Vitamin D is mostly safe in normal doses, but excessive intake can be harmful. Following advised limits helps avoid side effects.

For fish oil, studies have found it is usually safe. The FDA states that up to 3 grams per day is safe. However, fish oil can sometimes thin the blood, which may concern individuals with certain health conditions.

Research also shows that taking vitamin D and fish oil together is safe. Some studies suggest this combination might help lower the risk of autoimmune diseases.

Overall, both treatments have a strong safety record when used correctly. Consulting a healthcare provider before starting any new supplement is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the potential benefits of combining Vitamin D and fish oil for overall health improvement. Unlike standard treatments that often address specific conditions with pharmaceuticals, these supplements are derived from natural sources, aiming to provide a holistic boost to the body's well-being. Vitamin D3 is known for supporting bone health and immune function, while fish oil, rich in omega-3 fatty acids like EPA and DHA, may promote heart health and reduce inflammation. This combination could offer a unique, natural approach to enhancing health beyond what current medications offer.

What evidence suggests that this trial's treatments could be effective for reducing the risk of cancer, heart disease, stroke, autoimmune disease, systemic inflammation, and chronic knee pain?

Research has shown that omega-3 fatty acids in fish oil, which participants in this trial may receive, can lower triglyceride levels and may reduce the risk of heart problems, particularly in individuals with a low risk of heart disease. Some studies suggest that omega-3s can improve heart health and might lower the chance of dying from heart-related issues. For vitamin D, another treatment option in this trial, research suggests it can support bone health by aiding calcium absorption and may slightly lower the risk of dying from cancer. Evidence also indicates that vitamin D might reduce the risk of autoimmune diseases and heart issues. Taking vitamin D and fish oil together, as tested in one of the trial arms, might lower cancer risk and help control blood sugar levels. Overall, both supplements show promise for improving health in various ways. ^{1 6 7 8 9}

Who Is on the Research Team?

Karen H Costenbader, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for U.S. men and women without a history of cancer, heart disease, or stroke. It's focused on those with chronic knee pain due to conditions like rheumatoid arthritis and aims to see if vitamin D3 or fish oil supplements can help.

Inclusion Criteria

I frequently experience chronic knee pain.

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 to assess effects on autoimmune disease, inflammation, and knee pain

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including annual questionnaires for knee pain and blood sample analysis for inflammation biomarkers

1 year

Extension

Observational follow-up for the development of new autoimmune diseases post trial closure

7 years

What Are the Treatments Tested in This Trial?

Interventions

• Fish Oil
• Placebo Pill
• Vitamin D

Trial Overview The study tests whether daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of autoimmune diseases, lower inflammation markers, or alleviate chronic knee pain in participants.

How Is the Trial Designed?

Group I: Vitamin D and Fish Oil Experimental Treatment 2 Interventions

Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Group II: Vitamin D Experimental Treatment 2 Interventions

Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.

Group III: Fish Oil Experimental Treatment 2 Interventions

Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Group IV: placebo Placebo Group 1 Intervention

Subjects will receive placebo pill.

Vitamin D is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Approved in European Union as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Approved in Canada as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Citations

1. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Fish oil and other LC omega-3 supplements lower triglyceride levels and might reduce the risk of some cardiovascular endpoints, especially among people with low ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322009620

Omega-3 Fatty Acids EPA and DHA: Health Benefits ... EPA and DHA have been linked to promising results in prevention, weight management, and cognitive function in those with very mild Alzheimer's disease. Previous ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00277-7/fulltext

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 ...

4. bmjmedicine.bmj.com bmjmedicine.bmj.com/content/3/1/e000451

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 ...

5. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(24)00101-0/fulltext

Bringing the Potential Benefits of Omega-3 to a Higher Level There is increasing evidence that higher doses of omega-3 are safe and may reduce adverse CVD events in patients with high risk of CVD as well ...

6. redox.com redox.com/wp-content/sds/1494.pdf

Safety Data Sheet Omega-3 Fatty Acids - Redox Fire may produce irritating and/or toxic fumes/vapours. SAFETY DATA SHEET OMEGA-3 FATTY ACIDS REVISION 5, DATE 01 APR 2022. Form 21047, Revision ...

7. mayoclinic.org mayoclinic.org/drugs-supplements-fish-oil/art-20364810

Fish oil Take fish oil supplements under a doctor's supervision. Safety and side effects. When taken as recommended, fish oil supplements are generally considered safe.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0273230010001480

Safety assessment of EPA-rich oil produced from yeast The USFDA accepts a generally recognized as safe (GRAS) limit for fish oil (EPA + DHA) of 3 grams/day, with a recommended limit of 2 g/day of EPA + DHA from ...

9. ahajournals.org ahajournals.org/doi/10.1161/01.cir.0000038493.65177.94

Fish Consumption, Fish Oil, Omega-3 Fatty Acids, and ... Since the first omega-3 fatty acid advisory,1 the FDA has ruled that intakes of up to 3 g/d of marine omega-3 fatty acids are GRAS (Generally Recognized As ...