Selenium and Immune Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279812
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : March 21, 2011
Food Standards Agency, United Kingdom
Information provided by:
Quadram Institute

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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Selenomethionine (supplement) and selenium enriched onions Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Selenium and Immune Function
Study Start Date : April 2005
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cellular and humoral immune response

Secondary Outcome Measures :
  1. Selenium status
  2. Selenoproteins and Se-biomarkers

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279812

United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Quadram Institute
Food Standards Agency, United Kingdom
Principal Investigator: Susan J Fairweather-Tait, BSc., MSc., PhD., DSc University of East Anglia

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00279812     History of Changes
Other Study ID Numbers: IFR02/2005
FSA 51949F
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: March 21, 2011
Last Verified: March 2011

Keywords provided by Quadram Institute:
Immune response
Selenium enriched foods
Selenium status
Selenium biomarkers

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances