Effects of long-term daily supplementation with vitamin D3 and marine omega-3 fatty acids on change in ADRD biomarkers: A secondary analysis of a randomized clinical trial.
Chirag M Vyas, Beth L Ostaszewski, Amirah K Anderson, Nancy R Cook, Jae H Kang, David Mischoulon, Charles F Reynolds, Grace Chang, Jennifer R Gatchel, JoAnn E Manson and 2 more
Article in Alzheimer's & dementia (New York, N. Y.). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01696435 (VITAL-DEP), which is not on this map. Not yet cited in PubMed.
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1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL
TypeinterventionalSponsorBrigham and Women's HospitalRan2010 to 2025Enrolled18,353ConditionsDepression, Depressive Symptoms, MoodArmsvitamin D3, omega-3 fatty acids (fish oil), Fish oil placebo, Vitamin D placebo
3 · Its place in the literature
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4 · The record
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5 · Who and what money
Authors and funding
12 authors.
Chirag M VyasDepartment of Psychiatry Massachusetts General Hospital and Harvard Medical School Boston Massachusetts USA.
Beth L OstaszewskiAnn Romney Center for Neurologic Diseases Department of Neurology Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA.
Amirah K AndersonAnn Romney Center for Neurologic Diseases Department of Neurology Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA.
Nancy R CookDivision of Preventive Medicine Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA.
Jae H KangChanning Division of Network Medicine Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA.
David MischoulonDepartment of Psychiatry Massachusetts General Hospital and Harvard Medical School Boston Massachusetts USA.
Charles F ReynoldsDepartment of Psychiatry UPMC and University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA.
Grace ChangDepartment of Psychiatry Harvard Medical School Boston Massachusetts USA.
Jennifer R GatchelDepartment of Psychiatry Massachusetts General Hospital and Harvard Medical School Boston Massachusetts USA.
JoAnn E MansonDivision of Preventive Medicine Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA.
Dennis J SelkoeAnn Romney Center for Neurologic Diseases Department of Neurology Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts USA.
Olivia I OkerekeDepartment of Psychiatry Massachusetts General Hospital and Harvard Medical School Boston Massachusetts USA.
Funding
Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
VITamin D and omegA-3 triaL (VITAL)U01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2009 to 2014
$23.6M
The VITamin D and OmegA-3 TriaL (VITAL)R01CA138962 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI BURING, JULIE E., MANSON, JOANN ELISABETH · 2015 to 2019
$20.9M
RESEARCH METHODS COREP30MH090333 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REYNOLDS, CHARLES F. · 2011 to 2015
$8.3M
VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaLR01MH091448 · NIMH · BRIGHAM AND WOMEN'S HOSPITAL · PI OKEREKE, OLIVIA IFEOMA · 2010 to 2019
$6.5M
Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint PainR01AR059086 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI COSTENBADER, KAREN H · 2010 to 2021
$5.4M
The VITamin D and OmegA-3 TriaL (VITAL): Post-Intervention Follow-UpR01AT011729 · NCCIH · BRIGHAM AND WOMEN'S HOSPITAL · PI Jun Li, JoAnn Elisabeth Manson · 2021 to 2026
$5.2M
Randomized trial of vitamin D and omega-3 fatty acids for diabetic kidney diseaseR01DK088762 · NIDDK · UNIVERSITY OF WASHINGTON · PI DE BOER, IAN H · 2010 to 2019
$4.7M
Effect of Vitamin D and Omega-3 Fatty Acids on Blood Pressure and HypertensionR01HL102122 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI FORMAN, JOHN P, SESSO, HOWARD D · 2011 to 2016
$3.3M
Lung VITamin D and OmegA-3 TriaL (Lung VITAL)R01HL101932 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI GOLD, DIANE R · 2010 to 2014
$3.2M
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive DeclineR01AG036755 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI KANG, JAE H · 2010 to 2015
$2.6M
Diabetes Prevention in the Vitamin D and Omega-3 TrialR01DK088078 · NIDDK · BRIGHAM AND WOMEN'S HOSPITAL · PI PRADHAN, ARUNA DAS, SONG, YIQING · 2010 to 2014
introductionVitamin D3 and omega-3 supplementation may slow outcomes related to Alzheimer's disease and related dementias (ADRD), with variation by sex or race, but their effects on ADRD-associated biomarkers are unknown.
methodsIn this secondary analysis of a randomized clinical trial (RCT), we included 929 participants from the in-clinic subcohort of the VITamin D and OmegA-3 TriaL - a completed, placebo-controlled, 2×2 factorial trial testing vitamin D3 (2000 IU/day) and omega-3s (1 g/day) for cardiovascular disease and cancer prevention. Plasma ADRD biomarkers were assayed at baseline and 2- and/or 4-year follow-up. Study outcomes were longitudinal change in four ADRD biomarkers: N-terminal tau fragment (NT1), amyloid beta (Aβ)40:42, neurofilament-light (NfL), and glial fibrillary acidic protein (GFAP). Repeated-measures models were used, with sex and race were pre-specified effect modifiers.
resultsThe sample mean (SD) age was 65.0 (6.6) years; 49.2% were female, and 8.2% were Black adults. Neither vitamin D3 nor omega-3s, compared to placebo, significantly reduced ADRD biomarkers over 4 years. Pre-specified subgroup analyses suggested potential interactions by sex and race. Vitamin D3 supplementation resulted in a reduction in NT1 among males (-2.7%) but not females ( DISCUSSION: In this secondary analysis of a RCT, neither vitamin D3 nor omega-3s significantly reduced selected plasma ADRD biomarkers over 4 years. Potential differences were observed by sex and race in reductions of ADRD biomarkers in response to these supplements; however, these analyses were uncorrected for multiple hypothesis testing and should be interpreted cautiously as hypothesis-generating signals requiring replication.
trial registrationClinicalTrials.gov identifiers: c (VITAL); NCT01696435 (VITAL-DEP).
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.
Effects of long-term daily supplementation with vitamin D3 and marine omega-3 fatty acids on change in ADRD biomarkers: A secondary analysis of a randomized clinical trial. · full record | OpenQuestion