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Micronutrient Supplementation and Incidence of Common Cold

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.
ClinicalTrials.gov Identifier: NCT02119143
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : August 1, 2017
Medical University of Graz
Information provided by (Responsible Party):
Lamprecht Manfred PhD, PhD, Green Beat

Brief Summary:
This study investigates the effects of a dietary supplement - a cocktail of vitamins and minerals - on the incidence of common cold in a cohort of middle management employees.The primary outcome is defined as the number of duty days lost due to common cold/flu. Further, immune parameters and markers of redox biology/oxidative stress will be determined. The wellbeing in the cohort will be evaluated via questionnaires.

Condition or disease Intervention/treatment
Immune System Diseases Dietary Supplement: vitamines and minerals Dietary Supplement: placebo

Detailed Description:
randomized, double-blinded, placebo controlled trial 82 Subjects, men and women, 25 - 50 yrs, non-smokers, employees of middle management, 24 weeks of supplementation/placebo, 4 wk wash-out of all supplements and dietetic products, undersupply of fruit, vegetables (< 4 portions/day) and whole grain food (< 5x/wk)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Influence of Micronutrient Supplementation on Duty Days Lost Due to Flu/Common Cold, Immune System, Oxidative Stress and Wellbeing in a Cohort of Middle Management Employees
Study Start Date : April 2014
Primary Completion Date : January 2017
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Vitamines and minerals
41 middel aged subjects receive vitamin and mineral supplementation
Dietary Supplement: vitamines and minerals
given for 24 weeks, after 4 week wash out of all supplements and dietetic products
Placebo Comparator: cellulose
41 middle aged subjects get the placebo
Dietary Supplement: placebo
given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products

Primary Outcome Measures :
  1. Incidence of common cold [ Time Frame: 24 weeks ]
    vitamins and minerals might influence the incidence of common cold in middle aged management employees

Secondary Outcome Measures :
  1. change in immune markers [ Time Frame: 24 weeks ]
    cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention

Other Outcome Measures:
  1. change in redox biology [ Time Frame: 24 weeks ]
    micronutrients may influence redox biology of subjects

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • pre or peri-menopausal
  • non-smokers
  • sedentary or moderately trained
  • BMI: >20 and < 35kg/m2
  • undersupply of fruits, vegetables and whole grain food, fibres
  • contraceptives
  • wash-out

Exclusion Criteria:

  • post-menopausal
  • smokers
  • trained people
  • BMI out of inclusion range
  • adequate intake of vegetables, fruits and whole grain food, fibres
  • no adherence to wash-out

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 ClinicalTrials.gov identifier (NCT number): NCT02119143

Institute of Pathophysiology and Immunology
Graz, Styria, Austria, 8010
Sponsors and Collaborators
Green Beat
Medical University of Graz
Principal Investigator: Manfred Lamprecht, Prof Green Beat and Medical University of Graz

Responsible Party: Lamprecht Manfred PhD, PhD, Principal Investigator, Green Beat
ClinicalTrials.gov Identifier: NCT02119143     History of Changes
Other Study ID Numbers: 26-151 ex 13/14
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lamprecht Manfred PhD, PhD, Green Beat:
common cold, immunity, oxidative stress

Additional relevant MeSH terms:
Common Cold
Immune System Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs