VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL - Full Text View

Purpose

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil: 1) reduces risk of clinical depressive syndrome, 2) yields better mood scores over time, compared to placebo.

Condition	Intervention
Depression Depressive Symptoms Mood	Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Fish oil placebo Dietary Supplement: Vitamin D placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D

Drug Information available for: Cholecalciferol Vitamin D Fish oil Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Depression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Depression syndrome will be determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (e.g., PHQ) items.
Mood scores [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Mood scores will be evaluated by continuous scores on the mood scale (PHQ).


Enrollment:	25875
Study Start Date:	July 2010
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	October 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vitamin D + fish oil placebo Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo	Dietary Supplement: vitamin D3 Vitamin D3 (cholecalciferol), 2000 IU per day Other Name: cholecalciferol Dietary Supplement: Fish oil placebo Fish oil placebo
Active Comparator: Vitamin D placebo + fish oil 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])	Drug: omega-3 fatty acids (fish oil) 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]). Other Name: fish oil Dietary Supplement: Vitamin D placebo Vitamin D placebo
Active Comparator: Vitamin D placebo + fish oil placebo Vitamin D placebo Fish oil placebo	Dietary Supplement: Fish oil placebo Fish oil placebo Dietary Supplement: Vitamin D placebo Vitamin D placebo
Active Comparator: Vitamin D + fish oil 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])	Dietary Supplement: vitamin D3 Vitamin D3 (cholecalciferol), 2000 IU per day Other Name: cholecalciferol Drug: omega-3 fatty acids (fish oil) 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]). Other Name: fish oil

Detailed Description:

VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL is a randomized clinical trial of vitamin D (in the form of vitamin D3 [cholecalciferol]) and marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) supplements in the prevention of depression in older adults. Existing data from laboratory studies, epidemiologic research, limited clinical trials research suggest that these nutritional agents may reduce risk of depression or improve mood, but large primary prevention trials with adequate dosing and lengthy treatment durations in general populations are lacking.

Eligible participants will be assigned by chance (like a coin toss) to one of four groups: (1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. Participants have an equal chance of being assigned to any of these four groups and a 3 out of 4 chance of getting at least one active agent.

Participants in all groups will take two pills each day -- one softgel that contains either vitamin D3 or vitamin D placebo and one capsule that contains either omega-3 or omega-3 placebo. Participants will receive their study pills in convenient calendar packages via U.S. mail.

Participants will also fill out a short (15-20 minute) questionnaire each year. The questionnaire asks about health; lifestyle habits such as physical exercise, diet, and smoking; use of medications and dietary supplements; family history of illness, and new medical diagnoses. The questionnaire also includes specific questions pertaining to mood. Occasionally, participants may receive a phone call from study staff to collect information or to clarify responses on the questionnaire.

Primary aims of 1) reduction in risk of clinical depressive syndrome and 2) yielding of better mood scores over time will be address in the full VITAL cohort of 20,000. Secondary aims will be addressed in sub-set of participants. The secondary aims will address whether: 1) among a subset of 1,000 participants evaluated at a Clinical and Translational Science Center (CTSC), the agents reduce risk of depression and yield better mood scores among persons with known risk factors for late-life depression; 2) among a subset of 1,000 participants evaluated at a CTSC, the agents reduce risk of major depression and yield better mood scores among persons with sub-syndromal depressive symptoms; 3) among all VITAL participants, African-American race (African-Americans have high risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on late-life depression risk and on mood scores; 4) among a subset of participants, baseline plasma levels of vitamin D and omega-3 fatty acids are related to depression risk and/or modify agent effects.

Thus, VITAL-DEP will address simultaneously the impact of both vitamin D and fish oil for universal, selective and indicated prevention of late-life depression.

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study. These are the criteria specific for testing of the primary aims in the VITAL-DEP ancillary study:

no current significant depressive symptoms
no core major depressive disorder symptoms for a period of two or more weeks in the past two years
no history of alcohol and/or substance abuse disorder active in the past 12 months, schizophrenia or other primary psychotic disorder, bipolar disorder, post-traumatic stress disorder or obsessive-compulsive disorder
no psychiatric hospitalization in the past 2 years
no current psychotherapy or current use of psychotropics (including non-prescription agents for the treatment of mood disorders), except for limited use of mild sedatives/hypnotics
no history of major neurologic disorder or delirium episode in the past 12 months
no history of clinical (i.e., overt and not sub-clinical) hypothyroidism diagnosis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696435

Locations


United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Brigham and Women's Hospital

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Olivia I Okereke, MD, SM	Brigham and Women's Hospital

More Information

Additional Information:

Welcome to the VITAL study website This link exits the ClinicalTrials.gov site


Responsible Party:	Olivia Okereke, Olivia I. Okereke, MD, SM, Principal Investigator, Brigham and Women's Hospital, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01696435 History of Changes
Other Study ID Numbers:	2010-P-001881 R01MH091448
Study First Received:	September 24, 2012
Last Updated:	July 19, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:


Depression Depressive Symptoms Mood Geriatric Prevention

Additional relevant MeSH terms:


Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Vitamins Vitamin D	Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 27, 2016

VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL (VITAL-DEP)