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

Primary Purpose

Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitamin D3
omega-3 fatty acids (fish oil)
Vitamin D3 placebo
Fish oil placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

60 Years - 92 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids

ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids

PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids

PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids

Arm 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]).

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

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]).

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

Outcomes

Primary Outcome Measures

Change in Global Composite Score for Cognitive Decline
We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.

Secondary Outcome Measures

Change in Episodic Memory Score for Cognitive Decline
The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01.
Change in Executive Function Score for Cognitive Decline
The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006.
Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.
Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05

Full Information

First Posted
August 17, 2012
Last Updated
March 30, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01669915
Brief Title
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Acronym
VITAL-Cog
Official Title
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2011 (Actual)
Primary Completion Date
June 8, 2016 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
Arm Type
Active Comparator
Arm 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]).
Arm Title
ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
Arm Type
Active Comparator
Arm Description
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
Arm Title
PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
Arm Type
Active Comparator
Arm 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]).
Arm Title
PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
Arm Type
Placebo Comparator
Arm Description
PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Vitamin D3 (cholecalciferol), 2000 IU per day
Intervention Type
Drug
Intervention Name(s)
omega-3 fatty acids (fish oil)
Intervention Description
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]).
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 placebo
Intervention Description
Vitamin D placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil placebo
Intervention Description
Fish oil placebo
Primary Outcome Measure Information:
Title
Change in Global Composite Score for Cognitive Decline
Description
We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.
Time Frame
Change over two assessments (baseline, 2.8 years).
Secondary Outcome Measure Information:
Title
Change in Episodic Memory Score for Cognitive Decline
Description
The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01.
Time Frame
Change over two assessments (baseline, 2.8 years)
Title
Change in Executive Function Score for Cognitive Decline
Description
The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006.
Time Frame
Change over two assessments (baseline, 2.8 years)
Title
Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.
Description
Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05
Time Frame
Change over two assessments (baseline, 2.8 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study: are aged 60 or more have no hearing impairment indicate a willingness on the run-in phase to participate in a cognitive sub-study.
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34853363
Citation
Kang JH, Vyas CM, Okereke OI, Ogata S, Albert M, Lee IM, D'Agostino D, Buring JE, Cook NR, Grodstein F, Manson JE. Effect of vitamin D on cognitive decline: results from two ancillary studies of the VITAL randomized trial. Sci Rep. 2021 Dec 1;11(1):23253. doi: 10.1038/s41598-021-02485-8.
Results Reference
derived
Links:
URL
http://www.vitalstudy.org
Description
VITAL study website link

Learn more about this trial

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

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