Influences of Multivitamin Supplementation on Health Parameters

Not Applicable

Completed

• Conditions: Health Behavior
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: multivitamin supplement

• Registration Number: NCT03071796
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-03-01
• Study Start: 2017-03-07
• Study First Posted: 2017-03-07
• Status Verified: 2017-06
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-20
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	liquids with similar appearance and taste like multivitamin supplement for 12 weeks
multivitamin supplement	multivitamin supplement	liquid multivitamin supplement for 12 weeks

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Vitamin B12	change measures (baseline to 12 weeks)	vitamin B12 \[pmol/l\]

Secondary Outcome Measures

Name	Time	Method
Analysis of blood pressure	change measures (baseline to 12 weeks)	blood pressure
Analysis of heart rate variability	change measures (baseline to 12 weeks)	heart rate variability
Analysis of speed of pulse wave,	change measures (baseline to 12 weeks)	speed of pulse wave
Plasma concentration of 25-hydroxyvitamin D	change measures (baseline to 12 weeks)	25-hydroxyvitamin D \[nmol/l\]
Plasma concentration of folic acid	change measures (baseline to 12 weeks)	folic acid \[nmol/l\]
Plasma concentration of homocysteine	change measures (baseline to 12 weeks)	homocysteine \[µmol/l\]
Plasma concentration of HbA1c	change measures (baseline to 12 weeks)	HbA1c \[mmol\]

Trial Locations

Locations (1)

University of Halle-Wittenberg; 🇩🇪 Halle (Saale), Germany