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NCT03203096 Clinical Trial

Magnesium Supplementation in Stress Conditions

Stress Physiology Clinical Trial

Official title:
Randomized, Double-blind, Placebo-controlled Intervention Study About the Effects of Magnesium Supplementation Using Nutritional Supplements on the Stress Parameters of Students Preparing for Examination

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03203096
Other study ID # StressMag2017
Secondary ID
Status Completed
Phase N/A
First received June 22, 2017
Last updated June 26, 2017
Start date January 15, 2017
Est. completion date June 6, 2017

Study information
Verified date June 2017
Source Protina Pharmazeutische GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine how a 6-week magnesium supplementation with 400 mg magnesium from magnesium citrate/magnesium oxide affects stress parameters in students in exam preparation.

Description:

The examinations are carried out in 70 students in exam preparation (6 weeks before exam). The target parameters are determined in blood and 24h-urine. Blood sampling takes place at confinement, after 3 weeks and at the end of the study (week 6). In addition, heart rate variability is determined.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date June 6, 2017
Est. primary completion date June 6, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy students in exam preparation

Exclusion Criteria:

- pregnancy

- any chronic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Magnesium
Magnesium citrate / Magnesium oxide
• Placebo

Locations
Country Name City State
Slovakia Biomed Martin Martin

Sponsors (2)
Lead Sponsor Collaborator
Protina Pharmazeutische GmbH Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary blood sampling measurement of stress metabolites 6 weeks
Primary 24h-urine measurement of stress metabolites 6 weeks
Primary heart rate variability measurement of heart rate variability 6 weeks
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