Micronutrient Supplementation and Incidence of Common Cold
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
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 1, 2017
July 1, 2017
2.8 years
April 17, 2014
July 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of common cold
vitamins and minerals might influence the incidence of common cold in middle aged management employees
24 weeks
Secondary Outcomes (1)
change in immune markers
24 weeks
Other Outcomes (1)
change in redox biology
24 weeks
Study Arms (2)
Vitamines and minerals
ACTIVE COMPARATOR41 middel aged subjects receive vitamin and mineral supplementation
cellulose
PLACEBO COMPARATOR41 middle aged subjects get the placebo
Interventions
given for 24 weeks, after 4 week wash out of all supplements and dietetic products
given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- post-menopausal
- smokers
- trained people
- adequate intake of vegetables, fruits and whole grain food, fibres
- no adherence to wash-out
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Green Beatlead
- Medical University of Grazcollaborator
Study Sites (1)
Institute of Pathophysiology and Immunology
Graz, Styria, 8010, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred Lamprecht, Prof
Green Beat and Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 17, 2014
First Posted
April 21, 2014
Study Start
April 1, 2014
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
August 1, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share