TABLE 3.
VITAL‐COG (n = 3424; telephone assessments) | CTSC‐COG (n = 794; in‐person assessments) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
N‐3 group | Placebo group | N‐3 group | Placebo group | ||||||||
N | Mean (SE) ‡ | N | Mean (SE) ‡ | Difference in score at each timepoint (N3 group – placebo group;95% CI) ‡ | N | Mean (SE) ‡ | N | Mean (SE) ‡ | Difference in score at each timepoint (N3 group – placebo group; 95% CI) ‡ | ||
Cognitive tests common to the two substudies † | Cognitive tests common to the two substudies † | ||||||||||
TICS 10 words ‐immediate recall | Difference in score ‡ |
TICS 10 words immediate recall |
Difference in score ‡ | ||||||||
First assessment score | 14980 | 4.65 (0.04) | 1486 | 4.66 (0.04) | –0.01 (–0.13, 0.11) | First assessment score ‡ | 385 | 4.69 (0.07) | 391 | 4.78 (0.06) | –0.09 (–0.28, 0.09) |
Second assessment score | 1440 | 4.66 (0.04) | 1483 | 4.76 (0.04) | –0.10 (–0.22, 0.03) | Second assessment score ‡ | 251 | 4.88 (0.09) | 264 | 4.93 (0.08) | –0.05 (–0.28, 0.19) |
TICS 10 words ‐ delayed recall |
Difference in score ‡ |
TICS 10 words ‐ delayed recall |
Difference in score ‡ | ||||||||
First assessment score | 14980 | 2.67 (0.05) | 1486 | 2.73 (0.05) | –0.06 (–0.19, 0.08) | First assessment score ‡ | 385 | 1.92 (0.09) | 391 | 2.01 (0.09) | –0.09 (–0.33, 0.15) |
Second assessment score | 1440 | 2.66 (0.05) | 1483 |
2.78 (0.05) |
–0.12 (–0.26, 0.03) | Second assessment score ‡ | 251 | 2.13 (0.10) | 264 | 2.31 (0.11) | –0.18 (–0.48, 0.11) |
EBMT – immediate recall |
Difference in score ‡ |
EBMT – immediate recall |
Difference in score ‡ | ||||||||
First assessment score | 14980 | 9.60 (0.04) | 1486 | 9.57 (0.04) | 0.03 (–0.09, 0.15) | First assessment score ‡ | 385 | 9.71 (0.09) | 391 | 9.77 (0.08) | –0.06 (–0.29, 0.17) |
Second assessment score | 1440 | 9.48 (0.05) | 1483 | 9.60 (0.05) | –0.12 (–0.25, 0.01) | Second assessment score ‡ | 251 | 9.96 (0.10) | 264 | 10.03 (0.10) | –0.07 (–0.34, 0.20) |
EBMT – delayed recall |
Difference in score ‡ |
EBMT – delayed recall |
Difference in score ‡ | ||||||||
First assessment score | 14980 | 9.25 (0.05) | 1486 | 9.21 (0.05) | 0.04 (–0.09, 0.17) | First assessment score ‡ | 385 | 9.31 (0.09) | 391 | 9.35 (0.08) | –0.04 (–0.28, 0.20) |
2nd assessment score | 1440 | 9.13 (0.05) | 1483 | 9.18 (0.05) | –0.05 (–0.19, 0.10) | Second assessment score ‡ | 251 | 9.55 (0.10) | 264 | 9.57 (0.10) | –0.01 (–0.30, 0.27) |
Animal naming test | Difference in score ‡ | Animal naming test | Difference in score ‡ | ||||||||
First assessment score | 14980 | 19.34 (0.14) | 1486 | 19.47 (0.14) | –0.13 (–0.53, 0.26) | First assessment score ‡ | 385 | 20.81 (0.29) | 391 | 20.49 (0.31) | 0.32 (–0.52, 1.15) |
Second assessment score | 1440 | 19.14 (0.16) | 1483 | 19.30 (0.15) | –0.16 (–0.59, 0.27) | Second assessment score‡ | 251 | 20.09 (0.32) | 264 | 20.84 (0.33) | –0.76 (–1.66, 0.14) |
Cognitive tests unique to each substudy † | Cognitive tests unique to each substudy † | ||||||||||
Digit span backward | Difference in score ‡ | Vegetable naming test | Difference in score ‡ | ||||||||
First assessment score | 14980 | 6.75 (0.06) | 1486 | 6.81 (0.06) | –0.05 (–0.22, 0.12) | First assessment score ‡ | 385 | 15.31 (0.23) | 391 | 15.60 (0.23) | –0.29 (–0.93, 0.35) |
Second assessment score | 1440 | 2.07 (0.08) | 1483 |
1.94 (0.07) |
0.13 (–0.08, 0.33) | Second assessment score ‡ | 251 | 15.10 (0.26) | 264 | 15.23 (0.24) | –0.13 (–0.84, 0.58) |
Oral Trail Making Test – Part A |
Difference in score ‡ |
Trail Making Test – Part A |
Difference in score ‡ | ||||||||
First assessment score | 14980 | 10.41 (0.09) | 1486 | 10.52 (0.10) | –0.11 (–0.36, 0.15) | First assessment score ‡ | 385 | 29.89 (0.53) | 391 |
29.26 (0.53) |
0.63 (–0.84, 2.10) |
Second assessment score | 1440 | 10.19 (0.14) | 1483 | 10.30 (0.14) | –0.11 (–0.50, 0.28) | Second assessment score ‡ | 251 | 29.67 (0.56) | 264 |
29.35 (0.51) |
0.32 (–1.16, 1.81) |
Oral Trail Making Test – Part B |
Difference in score ‡ |
Trail Making Test – Part B |
Difference in score ‡ | ||||||||
First assessment score | 14980 | 39.16 (0.63) | 1486 | 38.27 (0.61) | 0.88 (–0.84, 2.60) | First assessment score ‡ | 385 | 82.24 (2.27) | 391 | 80.73 (2.13) | 1.51 (–4.60, 7.61) |
Second assessment score | 1440 | 38.96 (0.62) | 1483 | 38.94 (0.62) | 0.02 (–1.70, 1.75) | Second assessment score ‡ | 251 | 72.56 (1.76) | 264 | 73.63 (2.08) | –1.07 (–6.41, 4.27) |
Abbreviations: 3MS, Modified Mini‐Mental State Examination (range = 0–100); 25 CI, confidence interval; CTSC, Clinical and Translational Science Center for VITAL in Boston, MA; SE, standard error; TICS, Telephone Interview of Cognitive Status (range = 0–41); 19 VITAL, Vitamin D and Omega‐3 Trial.
In the VITAL‐Cog, 2483 completed both assessments, 501 completed only the baseline, 440 completed only the second assessment. In the CTSC‐Cog, 497 completed both assessments, 279 completed only the baseline, and 18 completed only the second assessment.
For a description of the tests, see previous section on VITAL‐Cog telephone cognitive function assessment section.
Least squares means and standard errors and differences of least squares means and standard errors were derived from univariate models.