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Influences of Multivitamin Supplementation on Health Parameters

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ClinicalTrials.gov Identifier: NCT03071796
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Kuno Hottenrott, Prof., Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date  ICMJE February 21, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date June 23, 2017
Actual Study Start Date  ICMJE March 7, 2017
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Plasma concentration of Vitamin B12 [ Time Frame: change measures (baseline to 12 weeks) ]
vitamin B12 [pmol/l]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03071796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Analysis of blood pressure [ Time Frame: change measures (baseline to 12 weeks) ]
    blood pressure
  • Analysis of heart rate variability [ Time Frame: change measures (baseline to 12 weeks) ]
    heart rate variability
  • Analysis of speed of pulse wave, [ Time Frame: change measures (baseline to 12 weeks) ]
    speed of pulse wave
  • Plasma concentration of 25-hydroxyvitamin D [ Time Frame: change measures (baseline to 12 weeks) ]
    25-hydroxyvitamin D [nmol/l]
  • Plasma concentration of folic acid [ Time Frame: change measures (baseline to 12 weeks) ]
    folic acid [nmol/l]
  • Plasma concentration of homocysteine [ Time Frame: change measures (baseline to 12 weeks) ]
    homocysteine [µmol/l]
  • Plasma concentration of HbA1c [ Time Frame: change measures (baseline to 12 weeks) ]
    HbA1c [mmol]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 1, 2017)
  • Susceptibility to infections [ Time Frame: up to 12 weeks ]
    Documentation of diseases in disease diary
  • assessment of life quality [ Time Frame: change measures (baseline to 12 weeks) ]
    use of questionnaires SF-36
  • assessment of mood [ Time Frame: change measures (baseline to 12 weeks) ]
    use of questionnaires POMS
  • assessment of perceived stress [ Time Frame: change measures (baseline to 12 weeks) ]
    use of questionnaires PSS-10
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Influences of Multivitamin Supplementation on Health Parameters
Official Title  ICMJE Influence of Liquid Multivitamin Supplementation on Life Quality, Mood, Perception of Stress and Health-related Vital and Blood Parameters and the Immune System
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
double-blind
Primary Purpose: Prevention
Condition  ICMJE Health Behavior
Intervention  ICMJE
  • Dietary Supplement: multivitamin supplement
    supplement includes 97 natural extracts
  • Dietary Supplement: Placebo
    liquids with similar appearance and taste like multivitamin supplement for 12 weeks
Study Arms  ICMJE
  • Experimental: multivitamin supplement
    liquid multivitamin supplement for 12 weeks
    Intervention: Dietary Supplement: multivitamin supplement
  • Placebo Comparator: placebo
    liquids with similar appearance and taste like multivitamin supplement for 12 weeks
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2017)
80
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
100
Actual Study Completion Date  ICMJE June 20, 2017
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy women and men
  • age between 30-60 years
  • employed

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071796
Other Study ID Numbers  ICMJE ILUG-201701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kuno Hottenrott, Prof., Martin-Luther-Universität Halle-Wittenberg
Study Sponsor  ICMJE Martin-Luther-Universität Halle-Wittenberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kuno Hottenrott, Prof. Dr. University of Halle-Wittenberg, Department of Sports
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP