Immune System DiseasesNCT02119143
Micronutrient Supplementation and Incidence of Common Cold
A study testing vitamines and minerals in people with Immune System Diseases, run by Green Beat at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Diseases
- What is being tested?
- vitamines and minerals
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Conditions
- Immune System Diseases
- Being tested
- vitamines and minerals, placebo
- Keywords
- common cold, immunity, oxidative stress
- Medical subject headings
- Immune System Diseases, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamines and mineralsDietary supplement
given for 24 weeks, after 4 week wash out of all supplements and dietetic products
placeboDietary supplement
given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products
| Study group | Role | What they receive |
|---|---|---|
| Vitamines and minerals | Active comparator | 41 middel aged subjects receive vitamin and mineral supplementation Receives: Dietary Supplement: vitamines and minerals |
| cellulose | Placebo comparator | 41 middle aged subjects get the placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of common cold
vitamins and minerals might influence the incidence of common cold in middle aged management employees
Measured: 24 weeks
Secondary outcomes (1)
change in immune markers
cytokine levels and expression of cytokine receptors in leucocytes may change over time due to micronutrient intervention
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Beat
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz
- Responsible party
- Principal investigator, Lamprecht Manfred PhD, PhD, Green Beat
- Investigators
- Manfred Lamprecht, Prof, Principal investigator, Green Beat and Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119143
- Sponsor's protocol ID
- 26-151 ex 13/14
- Status last verified
- Jul 2017
- First submitted
- 17 Apr 2014
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02119143
- Acronym / sponsor ID
- 26-151 ex 13/14
- Conditions
- Immune System Diseases
- Keywords
- common cold, immunity, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Green BeatUniversity, hospital or other
- Collaborators
- Medical University of Graz
- Study start
- Apr 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamines and minerals | Active comparator | Dietary Supplement: vitamines and minerals41 middel aged subjects receive vitamin and mineral supplementation |
| cellulose | Placebo comparator | Dietary Supplement: placebo41 middle aged subjects get the placebo |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- pre or peri-menopausal
- non-smokers
- sedentary or moderately trained
- BMI: >20 and < 35kg/m2
- undersupply of fruits, vegetables and whole grain food, fibres
Key exclusion criteria (6 listed)
- post-menopausal
- smokers
- trained people
- BMI out of inclusion range
- adequate intake of vegetables, fruits and whole grain food, fibres
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamines and mineralsgiven for 24 weeks, after 4 week wash out of all supplements and dietetic products | Dietary supplement | Vitamines and minerals |
| placebogiven for 24 weeks, after 4 weeks wash out of all supplements and dietetic products | Dietary supplement | cellulose |
Primary outcome
Incidence of common cold
Time frame: 24 weeks
vitamins and minerals might influence the incidence of common cold in middle aged management employees
1 secondary outcome
change in immune markers
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Lamprecht, Prof principal investigator
Green Beat and Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamines and minerals in people with Immune System Diseases, run by Green Beat at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of common cold (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.