|
Reference Study Country |
Design N randomised/completed Duration(a) Recruitment criteria |
Subject characteristics at baseline(b) | Intervention(b) | Outcomes assessed | Results |
|---|---|---|---|---|---|
|
Rayman et al. (2018) DK PRECISE Denmark |
RCT G1, placebo: 126 G2, 100 Se μg/d: 124 G3, 200 Se μg/d: 122 G4, 300 Se μg/d: 119 Duration: 5 yr (+ follow‐up for another 11 yr) Aged 60–74 yr; taking > 80% pills in the run‐in phase; SWOG performance‐status score ≤ 1; no active liver or kidney disease; no previous diagnosis of cancer (excluding NMSC); no diagnosed HIV infection; no immunosuppressive therapy; no use of Se supplements ≥ 50 μg/d in the previous 6 mo. |
Sex (% F): 48.1 Age (yr): 66.1 ± 4.1 Ethnicity: Caucasians Plasma Se (ng/g, median (IQR)) G1: 86 (15.2) G2: 87.5 (16.4) G3: 88.3 (16.2) G4: 83.9 (17.1) Se intake: NR |
Se‐enriched yeast (100 Se μg/d, 200 Se μg/d or 300 Se μg/d) vs placebo Adherence: NR Serum selenium at 5 yr, μg/L (median (IQR)) (from Winther et al., 2015) G1: 85 (16) G2: 157 (33) G3: 217 (46) G4: 271 (106) |
Vital status and date of death obtained from the Danish Civil Registration System |
N deaths; cumulative mortality (%) (95% CI); HR (95% CI) At end of 5‐yr intervention period G1: 8; 5.7 (3.0, 10.7); 1 (ref) G2: 6; 3.8 (1.7, 8.3); 0.75 (0.26, 2.16) G3: 5; 3.5 (1.5, 8.0); 0.64 (0.21, 1.94) G4: 12; 10.1 (6.2, 16.3); 1.62 (0.66, 3.96) After 16 yr (including 11 yr of follow up) G1: 35; 26.2 (19.6, 34.6); 1 (ref) G2: 41; 26.5 (20.1, 34.4); 1.15 (0.73, 1.80) G3: 35; 24.8 (18.4, 32.9); 0.99 (0.62, 1.59) G4: 47; 37.6 (29.8, 46.7); 1.59 (1.02, 2.46) |
|
Lippman et al. (2009) Klein et al. (2011) SELECT USA, Canada, Puerto Rico |
RCT G1, placebo: 8,696 G2, 200 μg Se/d: 8,752 Duration (median (min‐max)): 5.46 (4.17–7.33) yr (+ additional 3 yr of follow up) Aged ≥ 50 yr (African American men) or 55 yr or older (all other men); serum PSA ≤4 ng/mL; DRE not suspicious for prostate cancer |
Sex: M Age (yr, median (IQR)) G1: 63 (58–67) G2: 63 (58–68) Ethnicity (Caucasian, %): 79 Plasma Se (μg/L, median (IQR)) G1: 137.6 (124.7–151.8) G2: 135.0 (123.4–145.9) Se intake: NR |
L‐selenomethionine (200 μg Se/d) vs placebo Adherence, pill counts (%) G1: 85% at yr 1; 69% at yr 5 G2: 84% at yr 1; 69% at yr 5 Serum Se at 4 yr, μg/L (median (IQR)) G1: 140.1 (124.3–150.8) G2: 251.6 (218.7–275.0) |
Death ascertained through a search in Social Security Death Index for participants who had a last contact date ≥ 18 mo before the search. |
N deaths; HR (99% CI) End of intervention period G1: 382 l G2: 378; 0.99 (0.82, 1.19) After follow up period (including 3 yr of follow up) G1: 564 l G2: 551; 0.98 (0.84, 1.14) |
|
Marshall et al. (2011) USA |
RCT G1, placebo: 211 G2, 200 μg Se/d: 212 Duration: 3 yr Aged ≥ 40 yr; biopsy‐ confirmed diagnosis of High‐grade prostatic intraepithelial neoplasia with no evidence of cancer; PSA < 10 ng/mL; AUA symptom score < 20; ambulatory and able to carry out work of a light or sedentary nature. |
Sex: M Age (yr): ≥ 40 BMI < 25¦> 30 kg/m 2 (%) G1: 26.1¦27.5 G2: 21.7¦26.4 Ethnicity (White, %) G1: 76.8 G2: 83.5 Plasma Se, μg/L (median (IQR)) G1 (n = 51): 135.2 (113.3, 166.8) G2 (n = 46): 138.1 (104.7, 166.4) Se intake NR |
Selenomethionine (200 μg Se/d) vs placebo Adherence, pills count (%), at 1 yr; 3 yr G1: 90.8; 81.3 G2: 90.5; 78.9 Plasma Se (median, μg/L), at 1 yr; 3 yr G1 (n = 51): 145.7; 152.1 G2 (n = 46): 240.4; 261.2 |
Mortality; ascertainment method NR |
N deaths G1: 6 l G2: 4 |
|
Algotar et al. (2013b) NBT USA and New Zealand |
RCT G1, placebo: 232/0 G2, 200 μg Se/d: 234/0 G2, 400 μg Se/d: 233/0 Duration (median): 35 mo High risk of prostate cancer, as evidenced by prostate specific antigen (PSA) > 4 ng/mL and/or suspicious digital rectal examination and/or PSA velocity (rate of PSA change over time) > 0.75 ng/mL per year; undergone a prostate biopsy negative for cancer within 12 mo of enrolment. |
Sex: M Age (yr) G1: 65.5 ± 7.4 G2: 65.2 ± 8.0 G3: 65.5 ± 7.7 Ethnicity (Caucasians, %) G1: 84.2 G2: 83.7 G3: 82.6 Plasma Se (μg/L) G1: 124.5 ± 24.7 G2: 126.6 ± 26.9 G3: 127.2 ± 24.8 Se intake: NR |
Selenised yeast (200 μg Se/d or 400 μg Se/d or) vs placebo Adherence, pill counts (%) G1: 92.1 G2: 93.2 G3: 91.2 |
Mortality; ascertainment method NR |
N deaths G1: 5 l G2: 3 l G3: 2; p = 0.45 |
|
Clark et al. (1996) NPC USA |
RCT G1, placebo: 659 G2, 200 μg Se/d: 653 Duration (mean, max): 4.5 yr, 10.3 yr Confirmed histories of NMSC within the year before randomisation; estimated 5‐yr life‐expectancy; no cancer within the previous 5 yr. |
Sex (% F): G1: 24.4 G2: 26.2 Age (yr) G1: 63.0 ± 10.0 G2: 63.4 ± 10.2 Ethnicity: NR Plasma Se (μg/L) G1: 114.0 ± 21.2 G2: 114.4 ± 22.5 Se intake: NR |
Selenised yeast (200 μg Se/d) vs placebo Adherence (% self‐reporting missing taking a pill less than twice a month): 82 Increase in plasma Se at 9‐mo G1: no change G2: +67% |
Death ascertainment via medical records from death certificates. National Death Index searched each year for patients for whom vital status could not be ascertained. |
N deaths; HR (95% CI) (adjusted for age, sex and smoking status) G1: 129 l G2: 108; G2: 0.79 (0.61, 1.02) |
AUA: American Urological Association; BMI: body mass index; CI: confidence interval; d: day; DK: Denmark; DRE: digital rectal examination; F: females; Gx: group x; HIV: human immunodeficiency virus; HR: hazard ratio; IQR: interquartile range; M: males; mo: month; NBT: Negative Biopsy Trial; NMSC: non‐melanoma skin cancer; NPC: Nutritional Prevention of Cancer Trial; NR: not reported; PRECISE: PREvention of Cancer by Intervention with Selenium; PSA: prostate specific antigen; RCT: randomised controlled trial; Se: selenium; SELECT: Selenium and Vitamin E Cancer Prevention Trial; SWOG: Southwest Oncology Group; USA: United States of America; yr: year.
(a) Duration = duration of the treatment phase, unless specified otherwise.
(b): Mean ± SD, unless specified otherwise.