Table 1.
Baseline demographic characteristics and clinical biomarkers in the Vitamin D and Omega-3 Trial (VITAL) and the Women’s Health Study substudies.
| VITAL200 Substudy | ||||
|---|---|---|---|---|
| n-3 Treatment | Placebo | Total * | VITAL | |
| N | 100 | 100 | 200 | 25,871 |
| Age, y | 65 (60–71) | 64 (60–69) | 65 (60–70) | 67 (63–71) |
| African American, n | 50 (51%) | 49 (50%) | 99 (50%) | 5106 (20%) |
| Women, n | 53 (53%) | 51 (51%) | 104 (52%) | 13,085 (51%) |
| BMI ±, kg/m2 | 29 (25–3 3) | 28 (24–33) | 28 (25–3 3) | 27 (24–31) |
| HBPmed †, n | 63 (65%) | 59 (62%) | 122 (63%) | 13166 (51%) |
| Diabetes, n | 21 (21.2%) | 23 (23%) | 44 (22%) | 3686 (14.3%) |
| Current Smoker, n | 6 (6%) | 7 (7%) | 13 (7%) | 1836 (7%) |
| Statin Treatment, n | 35 (36%) | 40 (40%) | 75 (38%) | 8890 (35%) |
| Total Chol, mg/dL | 192 (169–210) | 187 (168–220) | 189 # (168–213) | 204 (179–232) |
| LDLC, mg/dL | 118 (100–1 36) | 112 (96–143) | 115 (96–138) | 124 (102–148) |
| HDLC, mg/dL | 47 (41–57) | 48 (37–56.2) | 47 (38–57) | 52 (42–65) |
| Trig, mg/dL | 108 (855–151) | 110 (81–141) | 109 (83–146) | 111 (83–155) |
| hsCRP, mg/L | 1.5 (0.8–4.0) | 1.7 (0.8–4.1) | 1.7 (0.8–4.1) | NA |
| IL6, pg/mL | 1.7 (1.0–2.2) | 1.7 (1.1–2.8) | 1.7 (1.1–2.5) | NA |
| TNRF2, ng/mL | 2651 (2104–3232) | 2459 (2051–3201) | 2530 (2068–3207) | NA |
| Substudy of the Women’s Health Study (Validation Cohort) | ||||
| Total | ||||
| N | 5129 | |||
| Age, y | 64 (61–68) | |||
| African American, n | 78 (2%) | |||
| Women, n | 5129 (100%) | |||
| BMI, kg/m2 | 25 (23–28) | |||
| HBPmed †, n | 1093 (21%) | |||
| Diabetes, n | 199 (4%) | |||
| Current Smoker, n | 492 (10%) | |||
| Statin Treatment, n | 314 (6%) | |||
| Total Chol, mg/dL | 220 (195–245) | |||
| LDLC, mg/dL | 130 (109–154) | |||
| HDLC, mg/dL | 52 (43–63) | |||
| Trig, mg/dL | 133 (94–190) | |||
| hsCRP, mg/L | 2.4 (1.1–4.8) | |||
| IL6, pg/mL | NA | |||
| TNRF2, ng/mL | NA | |||
# In VITAL lipid parameters were calculated in the sample of size 15,965; inflammatory biomarkers in a sample of 1561 subjects. N (%) or median (IQR); * None of the p-values of differences between groups were significant at 0.05 type 1 error (used the t-test for continuous variables, test of binomial proportion for count data); † high blood pressure (HBP) indicator was recorded in VITAL200 study and an indicator for high blood pressure treatment in the Women’s Health Study. ± BMI—body mass index; LDLC—low density lipoprotein cholesterol; HDLC—high density lipoprotein cholesterol; hsCRP—high sensitivity C-reactive protein; IL6—interleukin-6; TNRF2—tumor necrosis factor receptor 2.