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Vitamin D + Omega-3 for Depression (VITAL-DEP Trial)

N/A

Waitlist Available

Led By Olivia I Okereke, MD, SM

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No history of major neurologic disorder or delirium episode in the past 12 months

No core major depressive disorder symptoms for a period of two or more weeks in the past two years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5

Summary

This trial is studying whether taking vitamin D3 or omega-3 fatty acids supplements reduces the risk of developing cancer, heart disease, and stroke. This study will also examine whether either of these supplements reduces the risk of clinical depression or improves mood scores over time.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from omega-3s may include a fishy aftertaste, upset stomach, and nausea. Vitamin D might cause fatigue, weakness, dry mouth or a metallic taste. Placebos typically have no active ingredients but can still result in side effects due to the placebo effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had a major neurological disorder or delirium in the last year.

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I haven't had major depression symptoms for 2+ weeks in the last 2 years.

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I have never been diagnosed with overt hypothyroidism.

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I am not currently experiencing significant depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mood Scores

Number of Participants With a Depression Event

Other study objectives

Number of Participants With a Recurrent Depression Event

Number of Participants With an Incident Depression Event

Trial Design

4Treatment groups

Active Control

Group I: Vitamin D + fish oil placeboActive Control2 Interventions

Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo

Group II: Vitamin D placebo + fish oil placeboActive Control2 Interventions

Vitamin D placebo Fish oil placebo

Group III: Vitamin D + fish oilActive Control2 Interventions

Vitamin D3 (cholecalciferol), 2000 IU per day 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 \[DHA\])

Group IV: Vitamin D placebo + fish oilActive Control2 Interventions

Vitamin D placebo 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 \[DHA\])

0 / 4Eligibility criteria met