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Selenium and Immune Function

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ClinicalTrials.gov Identifier: NCT00279812
Recruitment Status : Completed
First Posted : January 20, 2006
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Food Standards Agency, United Kingdom
Information provided by (Responsible Party):
Quadram Institute

January 19, 2006
January 20, 2006
November 9, 2015
July 16, 2018
July 16, 2018
April 2005
August 2008   (Final data collection date for primary outcome measure)
Cellular and Humoral Immune Response [ Time Frame: 12 weeks ]
Total glutathione peroxidase 1 activity in platelets after supplementation
Cellular and Humoral Immune Response
Complete list of historical versions of study NCT00279812 on ClinicalTrials.gov Archive Site
  • Selenium Status [ Time Frame: 10 weeks ]
    Plasma selenium concentration after supplementation
  • Selenoproteins and Se-biomarkers [ Time Frame: 10 weeks ]
    Plasma selenoprotein P after the supllementation
  • Selenium Status
  • Selenoproteins and Se-biomarkers
Not Provided
Not Provided
 
Selenium and Immune Function
Selenium and Immune Function
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.

One of the proposed consequences of marginal selenium status is impaired immune function. Establishing the potential role of selenium as an enhancer of immune response in vivo may provide evidence-base for public health policy, with important consequences for preventing influenza and similar diseases in the elderly.

The project consists of a placebo controlled selenium supplementation study and a dietary intervention with un-enriched and selenium enriched onions. In a parallel group design, subjects will be given either one of three doses of Selenomethionine (50, 100 or 200µg selenium/day) or a placebo per day or selenium enriched or un-enriched onions (in the form of test meals) for 12 weeks. Changes in the expression of Se-responsive genes and proteins in blood will be measured and compared with changes in plasma Se concentration and selected selenoproteins. The relationship between dietary Se intake and systemic and mucosal immune responses to influenza vaccine will be examined. Changes in immune cell populations and the influence of Se on NK and CD8 cytotoxicity will be determined by flow cytometry.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Healthy
  • Dietary Supplement: 50ug selenium enriched yeast
    Selenomethionine supplement (50ug/d Se) for 12 weeks
  • Dietary Supplement: 100ug selenium enriched yeast
    Selenomethionine supplement (100ug/d Se) for 12 weeks
  • Dietary Supplement: 200ug selenium enriched yeast
    Selenomethionine supplement (200ug/d Se) for 12 weeks
  • Dietary Supplement: Control onion
    3 meals per week containing un-enriched onion (4ug/d) for 12 weeks
  • Dietary Supplement: Enriched onion
    3 meals per week containing un-enriched onion (50ug/d) for 12 weeks
  • Other: Placebo
    Placebo supplement for 12 weeks
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
  • Experimental: 50ug selenium enriched yeast
    50ug/d selenium enriched yeast (containing 60% selenomethionine)
    Intervention: Dietary Supplement: 50ug selenium enriched yeast
  • Experimental: 100ug selenium enriched yeast
    100ug/d selenium enriched yeast (containing 60% selenomethionine)
    Intervention: Dietary Supplement: 100ug selenium enriched yeast
  • Experimental: 200ug selenium enriched yeast
    200ug/d selenium enriched yeast (containing 60% selenomethionine)
    Intervention: Dietary Supplement: 200ug selenium enriched yeast
  • Experimental: Control onion
    3 meals/wk containing un-enriched onions equivalent to 4ug/d Se
    Intervention: Dietary Supplement: Control onion
  • Experimental: Enriched onion
    3 meals/wk containing enriched onions equivalent to 50ug/d Se
    Intervention: Dietary Supplement: Enriched onion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
144
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women, age 50-64
  • Plasma selenium level <1.2µmol/l (±10%)

Exclusion Criteria:

  • 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
  • Those planning a holiday/trip that requires immunisation during the twelve week intervention period
  • Parallel participation in another research project which involves dietary intervention or sampling of biological fluids/materials
  • Allergic to eggs or egg products
  • Allergic to chicken protein
  • Allergic to the antibiotic Gentamicin
  • A history of Guillain-Barre syndrome
Sexes Eligible for Study: All
50 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00279812
IFR02/2005
FSA 51949F ( Other Identifier: Food Standards Agency )
No
Not Provided
Not Provided
Quadram Institute
Quadram Institute
Food Standards Agency, United Kingdom
Principal Investigator: Susan J Fairweather-Tait, PhD University of East Anglia
Quadram Institute
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP