Selenium and Immune Function
2 other identifiers
interventional
133
1 country
1
Brief Summary
The aim of the study is to investigate the relationship between dose and form of selenium on immune function, and to identify functional markers of selenium status.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Apr 2005
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
July 16, 2018
CompletedJuly 16, 2018
September 1, 2017
3.3 years
January 19, 2006
November 9, 2015
September 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cellular and Humoral Immune Response
Total glutathione peroxidase 1 activity in platelets after supplementation
12 weeks
Secondary Outcomes (2)
Selenium Status
10 weeks
Selenoproteins and Se-biomarkers
10 weeks
Study Arms (6)
Placebo
PLACEBO COMPARATORPlacebo
50ug selenium enriched yeast
EXPERIMENTAL50ug/d selenium enriched yeast (containing 60% selenomethionine)
100ug selenium enriched yeast
EXPERIMENTAL100ug/d selenium enriched yeast (containing 60% selenomethionine)
200ug selenium enriched yeast
EXPERIMENTAL200ug/d selenium enriched yeast (containing 60% selenomethionine)
Control onion
EXPERIMENTAL3 meals/wk containing un-enriched onions equivalent to 4ug/d Se
Enriched onion
EXPERIMENTAL3 meals/wk containing enriched onions equivalent to 50ug/d Se
Interventions
Selenomethionine supplement (50ug/d Se) for 12 weeks
Selenomethionine supplement (100ug/d Se) for 12 weeks
Selenomethionine supplement (200ug/d Se) for 12 weeks
3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
Eligibility Criteria
You may qualify if:
- Men and women, age 50-64
- Plasma selenium level \<1.2µmol/l (±10%)
You may not qualify if:
- Elevated blood pressure measurements (\<90/50 or \<95/50 if symptomatic or \>160/100)
- Body mass index (BMI) \<18.5 or \>35
- Results of the clinical screening which are judged by the Human Nutrition Unit (HNU) Medical advisor to be indicative of a health problem and could compromise the well-being of the volunteer if they participated, or which would affect the data.
- Smokers
- Diagnosed with gastrointestinal disease (excluding hiatus hernia unless symptomatic or study intervention/procedure is contraindicated) for which they have been taking prescription drugs on a chronic basis.
- Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease.
- On regularly prescribed medication known to have a profound effect on the immune function
- Regularly using antacids and laxatives (at least once a week)
- Sufferers of hay-fever taking regular steroid medication
- Unwillingness to discontinue dietary (other than vitamins and minerals) or herbal supplements less than one month prior to the start of the study and for the duration of the study
- Blood donation within 16 weeks of the first study sample and who intend to donate blood less than 16 weeks after the last study sample
- Antibiotic use within four weeks prior to starting the study
- Those who receive or plan to receive any other type of immunisation during the study period
- Those who have received an immunisation within 6 months of the start of the study
- Intention to go on holiday/trips for more than 2 weeks during the twelve week intervention
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Food Research
Norwich, Norfolk, NR4 7UA, United Kingdom
Related Publications (3)
Ivory K, Prieto E, Spinks C, Armah CN, Goldson AJ, Dainty JR, Nicoletti C. Selenium supplementation has beneficial and detrimental effects on immunity to influenza vaccine in older adults. Clin Nutr. 2017 Apr;36(2):407-415. doi: 10.1016/j.clnu.2015.12.003. Epub 2015 Dec 24.
PMID: 26803169DERIVEDGoldson AJ, Fairweather-Tait SJ, Armah CN, Bao Y, Broadley MR, Dainty JR, Furniss C, Hart DJ, Teucher B, Hurst R. Effects of selenium supplementation on selenoprotein gene expression and response to influenza vaccine challenge: a randomised controlled trial. PLoS One. 2011 Mar 21;6(3):e14771. doi: 10.1371/journal.pone.0014771.
PMID: 21445287DERIVEDHurst R, Armah CN, Dainty JR, Hart DJ, Teucher B, Goldson AJ, Broadley MR, Motley AK, Fairweather-Tait SJ. Establishing optimal selenium status: results of a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2010 Apr;91(4):923-31. doi: 10.3945/ajcn.2009.28169. Epub 2010 Feb 24.
PMID: 20181815DERIVED
Results Point of Contact
- Title
- Dr Charlotte Armah
- Organization
- Institute of Food Research
Study Officials
- PRINCIPAL INVESTIGATOR
Susan J Fairweather-Tait, PhD
University of East Anglia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 20, 2006
Study Start
April 1, 2005
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 16, 2018
Results First Posted
July 16, 2018
Record last verified: 2017-09