Health BehaviorNCT03071796
Influences of Multivitamin Supplementation on Health Parameters
A study testing multivitamin supplement in people with Health Behavior, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
In this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. Furthermore the investigator will establish the effects on life quality, mood and perception of stress and will characterize changes on immune system. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- multivitamin supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 7 Mar 2017to 20 Jun 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women and men
- age between 30-60 years
- employed
Who cannot join
- acute and chronic diseases (including diabetes, inflammatory bowel diseases, dementia, multiple sclerosis)
- frequent use of alcohol, drugs or cigarettes (>5 cigarettes / day)
- use of additional supplements
- use of medications (e.g. antihypertensive medications, lipid reducers, thyroid medication)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Liquid Multivitamin Supplementation on Life Quality, Mood, Perception of Stress and Health-related Vital and Blood Parameters and the Immune System
In this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. Furthermore the investigator will establish the effects on life quality, mood and perception of stress and will characterize changes on immune system.
Read the detailed description
The double-blind, randomized intervention study is conducted for 12 weeks and includes two groups (placebo versus verum) with same number of participants.
The investigator aims to determine the effects of multivitamin supplement on blood and vital parameters which includes blood pressure, pulse, heart rate, variability of heart rate, vitamin D, vitamin B12, folic acid, homocysteine, HbA1c. Furthermore the investigator will access life quality, mood and perception of stress through the following questionnaire POMS, PSS-10, SF12 \& SF36. The investigator will evaluate whether the multivitamin supplement changes the frequency of diseases like cold which represents the function of the immune system.
- Conditions
- Health Behavior
- Being tested
- multivitamin supplement, Placebo
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multivitamin supplementDietary supplement
supplement includes 97 natural extracts
PlaceboDietary supplement
liquids with similar appearance and taste like multivitamin supplement for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| multivitamin supplement | Experimental | liquid multivitamin supplement for 12 weeks Receives: Dietary Supplement: multivitamin supplement |
| placebo | Placebo comparator | liquids with similar appearance and taste like multivitamin supplement for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Vitamin B12
vitamin B12 [pmol/l]
Measured: change measures (baseline to 12 weeks)
Secondary outcomes (7)
Analysis of blood pressure
blood pressure
Measured: change measures (baseline to 12 weeks)
Analysis of heart rate variability
heart rate variability
Measured: change measures (baseline to 12 weeks)
Analysis of speed of pulse wave,
speed of pulse wave
Measured: change measures (baseline to 12 weeks)
Plasma concentration of 25-hydroxyvitamin D
25-hydroxyvitamin D [nmol/l]
Measured: change measures (baseline to 12 weeks)
Plasma concentration of folic acid
folic acid [nmol/l]
Measured: change measures (baseline to 12 weeks)
Plasma concentration of homocysteine
homocysteine [µmol/l]
Measured: change measures (baseline to 12 weeks)
Plasma concentration of HbA1c
HbA1c [mmol]
Measured: change measures (baseline to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start7 Mar 2017
- Primary completion15 Jun 2017
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuno Hottenrott, Prof., Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Kuno Hottenrott, Prof. Dr., Principal investigator, University of Halle-Wittenberg, Department of Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071796
- Sponsor's protocol ID
- ILUG-201701
- Status last verified
- Jun 2017
- First submitted
- 21 Feb 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Liquid Multivitamin Supplementation on Life Quality, Mood, Perception of Stress and Health-related Vital and Blood Parameters and the Immune System
- ClinicalTrials.gov ID
- NCT03071796
- Acronym / sponsor ID
- ILUG-201701
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- 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.
In this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. Furthermore the investigator will establish the effects on life quality, mood and perception of stress and will characterize changes on immune system.
Detailed description
The double-blind, randomized intervention study is conducted for 12 weeks and includes two groups (placebo versus verum) with same number of participants.
The investigator aims to determine the effects of multivitamin supplement on blood and vital parameters which includes blood pressure, pulse, heart rate, variability of heart rate, vitamin D, vitamin B12, folic acid, homocysteine, HbA1c. Furthermore the investigator will access life quality, mood and perception of stress through the following questionnaire POMS, PSS-10, SF12 \& SF36. The investigator will evaluate whether the multivitamin supplement changes the frequency of diseases like cold which represents the function of the immune system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multivitamin supplement | Experimental | Dietary Supplement: multivitamin supplementliquid multivitamin supplement for 12 weeks |
| placebo | Placebo comparator | Dietary Supplement: Placeboliquids with similar appearance and taste like multivitamin supplement for 12 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy women and men
- age between 30-60 years
- employed
Key exclusion criteria (4 listed)
- acute and chronic diseases (including diabetes, inflammatory bowel diseases, dementia, multiple sclerosis)
- frequent use of alcohol, drugs or cigarettes (>5 cigarettes / day)
- use of additional supplements
- use of medications (e.g. antihypertensive medications, lipid reducers, thyroid medication)
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 |
|---|---|---|
| multivitamin supplementsupplement includes 97 natural extracts | Dietary supplement | multivitamin supplement |
| Placeboliquids with similar appearance and taste like multivitamin supplement for 12 weeks | Dietary supplement | placebo |
Primary outcome
Plasma concentration of Vitamin B12
Time frame: change measures (baseline to 12 weeks)
vitamin B12 [pmol/l]
7 secondary outcomes
Analysis of blood pressure
Time frame: change measures (baseline to 12 weeks)
Analysis of heart rate variability
Time frame: change measures (baseline to 12 weeks)
Analysis of speed of pulse wave,
Time frame: change measures (baseline to 12 weeks)
Plasma concentration of 25-hydroxyvitamin D
Time frame: change measures (baseline to 12 weeks)
Plasma concentration of folic acid
Time frame: change measures (baseline to 12 weeks)
Plasma concentration of homocysteine
Time frame: change measures (baseline to 12 weeks)
Plasma concentration of HbA1c
Time frame: change measures (baseline to 12 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 23 Jun 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.
Kuno Hottenrott, Prof. Dr. principal investigator
University of Halle-Wittenberg, Department of Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multivitamin supplement in people with Health Behavior, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 3 inclusion and 4 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 23 Jun 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 Germany. 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?
Plasma concentration of Vitamin B12 (time frame: change measures (baseline to 12 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 23 Jun 2017.