Trial Outcomes & Findings for Selenium and Immune Function (NCT NCT00279812)

Results Overview

Total glutathione peroxidase 1 activity in platelets after supplementation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

133 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-07-16

Participant Flow

Recruitment ran from May until the following February in 2005, 2006, and 2007. Study completed in June 2008. 272 volunteers completed a screening questionnaire,182 volunteers had blood samples screened, total of 133 were recruited and 119 completed the study.

Participant milestones

Participant milestones
Measure	Placebo Placebo Selenomethionine (supplement) and selenium enriched onions	50ug Selenium Enriched Yeast Selenomethionine supplement (50ug/d Se) for 12 weeks	100ug Selenium Enriched Yeast Selenomethionine supplement (100ug/d Se) for 12 weeks	200ug Selenium Enriched Yeast Selenomethionine supplement (200ug/d Se) for 12 weeks	Control Onion 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks	Enriched Onion 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Overall Study STARTED	21	26	24	23	20	19
Overall Study COMPLETED	20	20	21	23	17	18
Overall Study NOT COMPLETED	1	6	3	0	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo Selenomethionine (supplement) and selenium enriched onions	50ug Selenium Enriched Yeast Selenomethionine supplement (50ug/d Se) for 12 weeks	100ug Selenium Enriched Yeast Selenomethionine supplement (100ug/d Se) for 12 weeks	Control Onion 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks	Enriched Onion 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Overall Study Protocol Violation	1	1	0	1	0
Overall Study Withdrawal by Subject	0	4	2	0	0
Overall Study Adverse Event	0	1	1	2	1

Baseline Characteristics

Selenium and Immune Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=20 Participants Placebo Selenomethionine (supplement) and selenium enriched onions	50ug Selenium Enriched Yeast n=20 Participants Selenomethionine supplement (50ug/d Se) for 12 weeks	100ug Selenium Enriched Yeast n=21 Participants Selenomethionine supplement (100ug/d Se) for 12 weeks	200ug Selenium Enriched Yeast n=23 Participants Selenomethionine supplement (200ug/d Se) for 12 weeks	Control Onion n=17 Participants 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks	Enriched Onion n=18 Participants 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	23 Participants n=4 Participants	17 Participants n=21 Participants	18 Participants n=8 Participants	119 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	55.8 years STANDARD_DEVIATION 3.9 • n=5 Participants	56.5 years STANDARD_DEVIATION 4.6 • n=7 Participants	58.4 years STANDARD_DEVIATION 3.9 • n=5 Participants	56.1 years STANDARD_DEVIATION 3.9 • n=4 Participants	58.2 years STANDARD_DEVIATION 5.1 • n=21 Participants	57.7 years STANDARD_DEVIATION 4.2 • n=8 Participants	57.12 years STANDARD_DEVIATION 1.12 • n=8 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	54 Participants n=8 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	11 Participants n=21 Participants	12 Participants n=8 Participants	65 Participants n=8 Participants
Region of Enrollment United Kingdom	20 participants n=5 Participants	20 participants n=7 Participants	21 participants n=5 Participants	23 participants n=4 Participants	17 participants n=21 Participants	18 participants n=8 Participants	119 participants n=8 Participants
BMI	25 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants	26.1 kg/m^2 STANDARD_DEVIATION 3 • n=7 Participants	26.3 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants	25.9 kg/m^2 STANDARD_DEVIATION 3.8 • n=4 Participants	26.6 kg/m^2 STANDARD_DEVIATION 4.1 • n=21 Participants	26.1 kg/m^2 STANDARD_DEVIATION 2.4 • n=8 Participants	26 kg/m^2 STANDARD_DEVIATION 0.54 • n=8 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject

Total glutathione peroxidase 1 activity in platelets after supplementation

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo Selenomethionine (supplement) and selenium enriched onions	50ug Selenium Enriched Yeast n=18 Participants Selenomethionine supplement (50ug/d Se) for 12 weeks	100ug Selenium Enriched Yeast n=21 Participants Selenomethionine supplement (100ug/d Se) for 12 weeks	200ug Selenium Enriched Yeast n=23 Participants Selenomethionine supplement (200ug/d Se) for 12 weeks	Control Onion n=17 Participants 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks	Enriched Onion n=18 Participants 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Cellular and Humoral Immune Response	0.29 umol/min Standard Deviation 0.07	0.34 umol/min Standard Deviation 0.16	0.34 umol/min Standard Deviation 0.15	0.29 umol/min Standard Deviation 0.09	0.35 umol/min Standard Deviation 0.15	0.35 umol/min Standard Deviation 0.13

SECONDARY outcome

Timeframe: 10 weeks

Population: Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject

Plasma selenium concentration after supplementation

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo Selenomethionine (supplement) and selenium enriched onions	50ug Selenium Enriched Yeast n=18 Participants Selenomethionine supplement (50ug/d Se) for 12 weeks	100ug Selenium Enriched Yeast n=21 Participants Selenomethionine supplement (100ug/d Se) for 12 weeks	200ug Selenium Enriched Yeast n=23 Participants Selenomethionine supplement (200ug/d Se) for 12 weeks	Control Onion n=17 Participants 3 meals per week containing un-enriched onion (4ug/d) for 12 weeks	Enriched Onion n=18 Participants 3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Selenium Status	93.7 ng/mL Standard Deviation 16.5	118.3 ng/mL Standard Deviation 13.1	152.0 ng/mL Standard Deviation 24.3	177.4 ng/mL Standard Deviation 26.3	94.2 ng/mL Standard Deviation 15.0	106.0 ng/mL Standard Deviation 11.9

SECONDARY outcome

Timeframe: 10 weeks

Population: Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject

Plasma selenoprotein P after the supllementation