Influences of Multivitamin Supplementation on Health Parameters
Influence of Liquid Multivitamin Supplementation on Life Quality, Mood, Perception of Stress and Health-related Vital and Blood Parameters and the Immune System
1 other identifier
interventional
80
1 country
1
Brief 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.
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 Mar 2017
Shorter than P25 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
First Submitted
Initial submission to the registry
February 21, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedStudy Start
First participant enrolled
March 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2017
CompletedJune 23, 2017
June 1, 2017
3 months
February 21, 2017
June 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma concentration of Vitamin B12
vitamin B12 \[pmol/l\]
change measures (baseline to 12 weeks)
Secondary Outcomes (7)
Analysis of blood pressure
change measures (baseline to 12 weeks)
Analysis of heart rate variability
change measures (baseline to 12 weeks)
Analysis of speed of pulse wave,
change measures (baseline to 12 weeks)
Plasma concentration of 25-hydroxyvitamin D
change measures (baseline to 12 weeks)
Plasma concentration of folic acid
change measures (baseline to 12 weeks)
- +2 more secondary outcomes
Other Outcomes (4)
Susceptibility to infections
up to 12 weeks
assessment of life quality
change measures (baseline to 12 weeks)
assessment of mood
change measures (baseline to 12 weeks)
- +1 more other outcomes
Study Arms (2)
multivitamin supplement
EXPERIMENTALliquid multivitamin supplement for 12 weeks
placebo
PLACEBO COMPARATORliquids with similar appearance and taste like multivitamin supplement for 12 weeks
Interventions
supplement includes 97 natural extracts
liquids with similar appearance and taste like multivitamin supplement for 12 weeks
Eligibility Criteria
You may qualify if:
- healthy women and men
- age between 30-60 years
- employed
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Halle-Wittenberg
Halle, 06120, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuno Hottenrott, Prof. Dr.
University of Halle-Wittenberg, Department of Sports
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double-blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.; University of Halle-Wittenberg, Department of Sports
Study Record Dates
First Submitted
February 21, 2017
First Posted
March 7, 2017
Study Start
March 7, 2017
Primary Completion
June 15, 2017
Study Completion
June 20, 2017
Last Updated
June 23, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share