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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

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.

Condition or disease Intervention/treatment Phase
Health Behavior Dietary Supplement: multivitamin supplement Dietary Supplement: Placebo Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Prevention
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
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: multivitamin supplement
liquid multivitamin supplement for 12 weeks
Dietary Supplement: multivitamin supplement
supplement includes 97 natural extracts

Placebo Comparator: placebo
liquids with similar appearance and taste like multivitamin supplement for 12 weeks
Dietary Supplement: Placebo
liquids with similar appearance and taste like multivitamin supplement for 12 weeks




Primary Outcome Measures :
  1. Plasma concentration of Vitamin B12 [ Time Frame: change measures (baseline to 12 weeks) ]
    vitamin B12 [pmol/l]


Secondary Outcome Measures :
  1. Analysis of blood pressure [ Time Frame: change measures (baseline to 12 weeks) ]
    blood pressure

  2. Analysis of heart rate variability [ Time Frame: change measures (baseline to 12 weeks) ]
    heart rate variability

  3. Analysis of speed of pulse wave, [ Time Frame: change measures (baseline to 12 weeks) ]
    speed of pulse wave

  4. Plasma concentration of 25-hydroxyvitamin D [ Time Frame: change measures (baseline to 12 weeks) ]
    25-hydroxyvitamin D [nmol/l]

  5. Plasma concentration of folic acid [ Time Frame: change measures (baseline to 12 weeks) ]
    folic acid [nmol/l]

  6. Plasma concentration of homocysteine [ Time Frame: change measures (baseline to 12 weeks) ]
    homocysteine [µmol/l]

  7. Plasma concentration of HbA1c [ Time Frame: change measures (baseline to 12 weeks) ]
    HbA1c [mmol]


Other Outcome Measures:
  1. Susceptibility to infections [ Time Frame: up to 12 weeks ]
    Documentation of diseases in disease diary

  2. assessment of life quality [ Time Frame: change measures (baseline to 12 weeks) ]
    use of questionnaires SF-36

  3. assessment of mood [ Time Frame: change measures (baseline to 12 weeks) ]
    use of questionnaires POMS

  4. assessment of perceived stress [ Time Frame: change measures (baseline to 12 weeks) ]
    use of questionnaires PSS-10



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071796


Locations
Germany
University of Halle-Wittenberg
Halle (Saale), Germany, 06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Kuno Hottenrott, Prof. Dr. University of Halle-Wittenberg, Department of Sports

Responsible Party: Kuno Hottenrott, Prof., Prof. Dr.; University of Halle-Wittenberg, Department of Sports, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT03071796     History of Changes
Other Study ID Numbers: ILUG-201701
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No