A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline (VITAL-Cog)

Mass General Brigham

Status: Completed

Conditions: Cognitive Decline

Treatments: Drug: omega-3 fatty acids (fish oil); Dietary Supplement: Fish oil placebo; Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: vitamin D3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01669915

R01AG036755 (U.S. NIH Grant/Contract)

2010P-000769

Details and patient eligibility

About

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 is associated with cognitive decline in 3000 older participants of VITAL.

Full description

Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set of participants: 1) among participants, African-American race (African-Americans have high risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3 fatty acids modify agent effects.

Enrollment: 3,424 patients

Sex: All

Ages: 60 to 92 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:

1. are aged 60 or more
2. have no hearing impairment
3. indicate a willingness on the run-in phase to participate in a cognitive sub-study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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3,424 participants in 4 patient groups, including a placebo group

ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids

Active Comparator group

Description:

ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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 \[DHA\]).

Treatment:

Drug: omega-3 fatty acids (fish oil)

Dietary Supplement: vitamin D3

ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids

Active Comparator group

Description:

ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day

Treatment:

Dietary Supplement: Fish oil placebo

Dietary Supplement: vitamin D3

PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids

Active Comparator group

Description:

PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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 \[DHA\]).

Treatment:

Drug: omega-3 fatty acids (fish oil)

Dietary Supplement: Vitamin D3 placebo

PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids

Placebo Comparator group

Description:

PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day

Treatment:

Dietary Supplement: Fish oil placebo

Dietary Supplement: Vitamin D3 placebo