Effect of Long-term Vitamin D 3 Supplementation vs Placebo on Risk of Depression or Clinically Relevant Depressive Symptoms and on Change in Mood Scores: A Randomized Clinical Trial
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Importance: Low levels of 25-hydroxyvitamin D have been associated with higher risk for depression later in life, but there have been few long-term, high-dose large-scale trials. Objective: To test the effects of vitamin D3 supplementation on late-life depression risk and mood scores. Design, Setting, and Participants: There were 18 353 men and women aged 50 years or older in the VITAL-DEP (Vitamin D and Omega-3 Trial-Depression Endpoint Prevention) ancillary study to VITAL, a randomized clinical trial of cardiovascular disease and cancer prevention among 25 871 adults in the US. There were 16 657 at risk for incident depression (ie, no depression history) and 1696 at risk for recurrent depression (ie, depression history but no treatment for depression within the past 2 years). Randomization occurred from November 2011 through March 2014; randomized treatment ended on December 31, 2017, and this was the final date of follow-up. Intervention: Randomized assignment in a 2 × 2 factorial design to vitamin D3 (2000 IU/d of cholecalciferol) and fish oil or placebo; 9181 were randomized to vitamin D3 and 9172 were randomized to matching placebo. Main Outcomes and Measures: The primary outcomes were the risk of depression or clinically relevant depressive symptoms (total of incident and recurrent cases) and the mean difference in mood scores (8-item Patient Health Questionnaire depression scale [PHQ-8]; score range, 0 points [least symptoms] to 24 points [most symptoms]; the minimal clinically important difference for change in scores was 0.5 points). Results: Among the 18 353 randomized participants (mean age, 67.5 [SD, 7.1] years; 49.2% women), the median treatment duration was 5.3 years and 90.5% completed the trial (93.5% among those alive at the end of the trial). Risk of depression or clinically relevant depressive symptoms was not significantly different between the vitamin D3 group (609 depression or clinically relevant depressive symptom events; 12.9/1000 person-years) and the placebo group (625 depression or clinically relevant depressive symptom events; 13.3/1000 person-years) (hazard ratio, 0.97 [95% CI, 0.87 to 1.09]; P = .62); there were no significant differences between groups in depression incidence or recurrence. No significant differences were observed between treatment groups for change in mood scores over time; mean change in PHQ-8 score was not significantly different from zero (mean difference for change in mood scores, 0.01 points [95% CI, -0.04 to 0.05 points]). Conclusions and Relevance: Among adults aged 50 years or older without clinically relevant depressive symptoms at baseline, treatment with vitamin D3 compared with placebo did not result in a statistically significant difference in the incidence and recurrence of depression or clinically relevant depressive symptoms or for change in mood scores over a median follow-up of 5.3 years. These findings do not support the use of vitamin D3 in adults to prevent depression. Trial Registration: ClinicalTrials.gov Identifiers: NCT01169259 and NCT01696435.
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Two articles mention antidepressant treatment with or without combination with psychotherapy.
“Two articles mention antidepressant treatment with or without combination with psychotherapy (31, 32).”
From Administrative criteria in the relapse of depressive disorder: a critical appraisal (2026) · cites this paper as [32]
The VITAL-DEP randomized clinical trials did not detect evidence for efficacy of vitamin D or fish oils, relative to placebo, in preventing incident and recurrent major depressive episodes in older adults.
“The trials did not, however, detect evidence for efficacy, relative to placebo, with either nutraceutical, despite a cogent neurobiological rationale for positing the prophylactic effect of each, singly and in combination.”
From Mental health care for older adults: recent advances and new directions in clinical practice and research (2022) · cites this paper as [214]
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- Authors
- Okereke, O. I., Reynolds, C. F., Mischoulon, D., Chang, G., Vyas, C. M., Cook, N. R., Weinberg, A., Bubes, V., Copeland, T., Friedenberg, G., Lee, I.-M., Buring, J. E., & Manson, J. E.
- Affiliations
- Brigham and Women's Hospital (US)
- University of Pittsburgh (US)
- Harvard University (US)
- VA Boston Healthcare System (US)
- Corresponding author
- Okereke, Olivia I.
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2020-08-04
- Volume
- 324
- Issue
- 5
- Pages
- 471
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC7403921
- OpenAlex
- W3047395496
- Cited by
- 171
- References
- 31
- Citations by year
- 2026: 26 · 2025: 19 · 2024: 28 · 2023: 30 · 2022: 26 · 2021: 28 · 2020: 13 · 2019: 1
- FWCI
- 15.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Aging (R01AG036755)
- National Heart, Lung, and Blood Institute (R01HL102122, R01HL101932)
- National Institute of Mental Health (P30MH090333, R01MH091448)
- National Cancer Institute (U01CA138962, R01CA138962)
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK088078, R01DK088762)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR060574, R01AR059086)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Vitamin D Research Studies
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Keywords
- vitamin D3 supplementation, vitamin D3, depression, depressive symptoms, mood, geriatric depression, 25-hydroxyvitamin D, fish oil, omega-3 fatty acids, older adults, PHQ-8, depression prevention, VITAL trial, ancillary studies, cardiovascular disease prevention, cancer prevention
- MeSH terms
- Affect, Aged, Cholecalciferol, Depression, Depressive Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Surveys and Questionnaires, Recurrence, Vitamins, Incidence, Dietary Supplements
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