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Table 1.

Mean ± SE or frequency of all randomized eligible subjects and the subset who completed 15 months of treatment before the vitamin intervention

Total (n = 284)Randomized to treatment
Randomized to placebo
All (n = 142)Completed 15 months (n = 83)Did not complete 15 months (n = 59)All (n = 142)Completed 15 months (n = 93)Did not complete 15 months (n = 49)
Age 36.8 ± 0.6 36.9 ± 0.9 40.0 ± 1.1 32.5 ± 1.3 36.8 ± 0.9 39.0 ± 1.1 32.6 ± 1.4 
Gender        
    Female (%) 129 (45) 63 (44) 37 (45) 26 (44) 66 (46) 43 (46) 23 (47) 
    Male (%) 155 (55) 79 (56) 46 (55) 33 (56) 76 (54) 50 (54) 26 (53) 
Ethnicity        
    African American (%) 118 (42) 65 (46) 44 (53) 21 (36) 53 (37) 39 (42) 14 (29) 
    Caucasian (%) 109 (38) 49 (35) 26 (31) 23 (39) 60 (42) 41 (44) 19 (39) 
    Latino/Hispanic (%) 43 (15) 20 (14) 11 (13) 9 (15) 23 (16) 10 (11) 13 (26) 
Other (%) 14 (5) 8 (5) 2 (3) 6 (10) 6 (5) 3 (3) 3 (6) 
    Reported CPD 19.8 ± 0.5 19.1 ± 0.7 19.8 ± 0.9 18.2 ± 1.0 20.5 ± 0.8 21.2 ± 1.2 19.1 ± 1.0 
Cotinine at randomization 220.4 ± 6.7 224.5 ± 9.5 240.9 ± 12.2 201.5 ± 14.5 216.3 ± 9.6 229.6 ± 12.4 191.2 ± 14.1 
Adducts at randomization 0.80 ± 0.06 0.78 ± 0.09 0.76 ± 0.07 0.82 ± 0.19 0.82 ± 0.09 0.77 ± 0.08 0.91 ± 0.22 
GSTM1        
    +/+ or +/− (%) 183 (64) 89 (63) 52 (63) 37 (63) 94 (66) 62 (67) 32 (65) 
    −/− (%) 99 (35)* 51 (36)* 31 (37) 20 (34)* 48 (34) 31 (33) 17 (35) 
Total (n = 284)Randomized to treatment
Randomized to placebo
All (n = 142)Completed 15 months (n = 83)Did not complete 15 months (n = 59)All (n = 142)Completed 15 months (n = 93)Did not complete 15 months (n = 49)
Age 36.8 ± 0.6 36.9 ± 0.9 40.0 ± 1.1 32.5 ± 1.3 36.8 ± 0.9 39.0 ± 1.1 32.6 ± 1.4 
Gender        
    Female (%) 129 (45) 63 (44) 37 (45) 26 (44) 66 (46) 43 (46) 23 (47) 
    Male (%) 155 (55) 79 (56) 46 (55) 33 (56) 76 (54) 50 (54) 26 (53) 
Ethnicity        
    African American (%) 118 (42) 65 (46) 44 (53) 21 (36) 53 (37) 39 (42) 14 (29) 
    Caucasian (%) 109 (38) 49 (35) 26 (31) 23 (39) 60 (42) 41 (44) 19 (39) 
    Latino/Hispanic (%) 43 (15) 20 (14) 11 (13) 9 (15) 23 (16) 10 (11) 13 (26) 
Other (%) 14 (5) 8 (5) 2 (3) 6 (10) 6 (5) 3 (3) 3 (6) 
    Reported CPD 19.8 ± 0.5 19.1 ± 0.7 19.8 ± 0.9 18.2 ± 1.0 20.5 ± 0.8 21.2 ± 1.2 19.1 ± 1.0 
Cotinine at randomization 220.4 ± 6.7 224.5 ± 9.5 240.9 ± 12.2 201.5 ± 14.5 216.3 ± 9.6 229.6 ± 12.4 191.2 ± 14.1 
Adducts at randomization 0.80 ± 0.06 0.78 ± 0.09 0.76 ± 0.07 0.82 ± 0.19 0.82 ± 0.09 0.77 ± 0.08 0.91 ± 0.22 
GSTM1        
    +/+ or +/− (%) 183 (64) 89 (63) 52 (63) 37 (63) 94 (66) 62 (67) 32 (65) 
    −/− (%) 99 (35)* 51 (36)* 31 (37) 20 (34)* 48 (34) 31 (33) 17 (35) 

NOTE: There were no significant differences between the group randomized to treatment and the group randomized to placebo. The 176 who completed the study differed only by age from the 108 who did not complete the 15-month follow-up. Those in the treatment group who completed 15 months had a higher baseline cotinine level than those who did not complete the 15-month follow-up.

*

Two subjects are missing genotype data.

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