Vitamin D + Omega-3 for Depression

(VITAL-DEP Trial)

Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily vitamin D3 or omega-3 fish oil supplements can improve mood and reduce the risk of developing depression. Participants will be divided into groups receiving either vitamin D, omega-3s, both, or placebos, and researchers will monitor changes in mood over time. Ideal candidates are those without significant depressive symptoms and who haven't recently experienced major depression or used mood-altering treatments. The goal is to determine if these supplements can naturally boost mood and mental well-being. As an unphased trial, this study allows participants to contribute to understanding how natural supplements might enhance mental well-being.

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

Yes, you must stop taking any current medications for mood disorders, except for mild sedatives or hypnotics.

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

Research has shown that vitamin D3 and omega-3 fatty acids are generally safe for most people. Past studies have found no major safety issues with the doses used in this trial. Vitamin D3 at 2000 IU per day and omega-3 fatty acids at 1 gram per day are common supplement amounts.

For omega-3 fatty acids, research suggests they may help lower the risk of depression and are usually safe at this dose. Some people might experience minor stomach upset or a fishy aftertaste, but serious side effects are rare.

Vitamin D3 is also considered safe at 2000 IU daily. It helps maintain strong bones and supports the immune system. Very high doses can cause problems like kidney stones, but this trial uses a safe amount.

Overall, both supplements are widely used and have a good safety record. However, it is important to consult a healthcare provider before starting any new supplement.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using Vitamin D3 and Omega-3 fatty acids for depression because they offer a natural alternative to traditional antidepressants like SSRIs and SNRIs. Unlike most antidepressants, which work by altering neurotransmitter levels in the brain, this combination focuses on reducing inflammation and improving brain health. Vitamin D3 is thought to support mood regulation, while Omega-3s, such as EPA and DHA, are known for their anti-inflammatory properties and benefits to brain function. This approach might offer a gentler side-effect profile and appeal to individuals seeking non-pharmaceutical interventions.

What evidence suggests that this trial's treatments could be effective for depression?

Research shows that omega-3 fatty acids, one of the treatments in this trial, may help with depression. Studies indicate that omega-3s, especially those with high levels of EPA (a type of omega-3), can improve mood. Some research suggests they might be particularly helpful for people with mild to moderate depression. In contrast, the effects of vitamin D3, another treatment option in this trial, on mood remain less clear. Some studies find little difference in mood improvement compared to a placebo. However, both omega-3 and vitamin D3 are believed to support brain health by reducing inflammation and improving blood flow. While there is potential, more research is needed to confirm these benefits.13678

Who Is on the Research Team?

OI

Olivia I Okereke, MD, SM

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults in the VITAL study without a history of major neurological disorders, clinical hypothyroidism, significant depression, or recent substance abuse. They shouldn't be on psychotherapy or psychotropics (except mild sedatives) and must not have had core depressive symptoms for two weeks in the past two years.

Inclusion Criteria

I am not currently in psychotherapy or taking any mood-altering drugs, except for mild sleep aids.
I haven't had a major neurological disorder or delirium in the last year.
I haven't had major depression symptoms for 2+ weeks in the last 2 years.
See 3 more

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, or their placebos, for the prevention of depression

5.3 years
Annual questionnaire and occasional phone calls

Follow-up

Participants are monitored for depression events and mood scores through annual questionnaires

5.3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Fish Oil Placebo
  • Omega-3 Fatty Acids (Fish Oil)
  • Vitamin D3
  • Vitamin D Placebo
Trial Overview The VITAL-DEP study tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can prevent clinical depression and improve mood over time compared to placebos in individuals without prior cancer, heart disease, or stroke.
How Is the Trial Designed?
4Treatment groups
Active Control
Group I: Vitamin D + fish oil placeboActive Control2 Interventions
Group II: Vitamin D placebo + fish oil placeboActive Control2 Interventions
Group III: Vitamin D + fish oilActive Control2 Interventions
Group IV: Vitamin D placebo + fish oilActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Omega-3 Fatty Acids Supplementation in the Treatment of ...The present study evaluated the effectiveness of omega-3 fatty acid supplements in alleviating depressive symptoms in patients with mild to moderate depression.
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/31383846/
Efficacy of omega-3 PUFAs in depression: A meta-analysisCurrent evidence supports the finding that omega-3 PUFAs with EPA ≥ 60% at a dosage of ≤1 g/d would have beneficial effects on depression.
Effect of Long-term Supplementation With Marine Omega-3 ...Daily omega-3 supplementation compared with placebo resulted in mixed findings of a statistically significant increase in risk of depression or clinically ...
Omega-3 fatty acids for inflamed depression – A match ...In this match-mismatch study n-3 fatty acids were effective in inflamed depression. N-3 fatty acids also improved symptoms of fatigue and sleeping difficulties.
Efficacy of omega-3 PUFAs in depression: A meta-analysisCurrent evidence supports the finding that omega-3 PUFAs with EPA ≥ 60% at a dosage of ≤1 g/d would have beneficial effects on depression.
Omega-3 fatty acids and the treatment of depressionThere are number of studies which shows that omega-3 fatty acids are proving to be very effective against the treatment of major depression disorder and other ...
Safety and Effectiveness of Omega 3-Fatty Acids, EPA ...Both types of omega-3 fatty acids are commonly found in fish oils. It is believed that a deficiency in these omega-3 fatty acids may lead to the ...
Efficacy and safety of omega-3 fatty acids supplementation for ...A meta-analysis of intervention studies showed that supplementation with more than 2 g/day did have positive effects on anxiety symptoms [23].
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