Influences of Multivitamin Supplementation on Health Parameters

Health Behavior Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071796
• Other study ID #: ILUG-201701
• Status: Completed
• Phase: N/A
• First received: February 21, 2017
• Last updated: June 22, 2017
• Start date: March 7, 2017
• Est. completion date: June 20, 2017

Study information

• Verified date: June 2017
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 20, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Health Behavior

Intervention

Dietary Supplement:
• multivitamin supplement
supplement includes 97 natural extracts
• Placebo
liquids with similar appearance and taste like multivitamin supplement for 12 weeks

Locations

Country	Name	City	State
Germany	University of Halle-Wittenberg	Halle (Saale)

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Susceptibility to infections	Documentation of diseases in disease diary	up to 12 weeks
Other	assessment of life quality	use of questionnaires SF-36	change measures (baseline to 12 weeks)
Other	assessment of mood	use of questionnaires POMS	change measures (baseline to 12 weeks)
Other	assessment of perceived stress	use of questionnaires PSS-10	change measures (baseline to 12 weeks)
Primary	Plasma concentration of Vitamin B12	vitamin B12 [pmol/l]	change measures (baseline to 12 weeks)
Secondary	Analysis of blood pressure	blood pressure	change measures (baseline to 12 weeks)
Secondary	Analysis of heart rate variability	heart rate variability	change measures (baseline to 12 weeks)
Secondary	Analysis of speed of pulse wave,	speed of pulse wave	change measures (baseline to 12 weeks)
Secondary	Plasma concentration of 25-hydroxyvitamin D	25-hydroxyvitamin D [nmol/l]	change measures (baseline to 12 weeks)
Secondary	Plasma concentration of folic acid	folic acid [nmol/l]	change measures (baseline to 12 weeks)
Secondary	Plasma concentration of homocysteine	homocysteine [µmol/l]	change measures (baseline to 12 weeks)
Secondary	Plasma concentration of HbA1c	HbA1c [mmol]	change measures (baseline to 12 weeks)