Magnesium Supplementation in Stress Conditions

June 26, 2017 updated by: Protina Pharmazeutische GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Martin, Slovakia, 03601
        • Biomed Martin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy students in exam preparation

Exclusion Criteria:

  • pregnancy
  • any chronic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
identically tasting and looking Placebo
Dietary supplement: Placebo
Active Comparator: Magnesium
Supplementation with 400 mg Magnesium from Magnesium Citrate / Magnesium Oxide once daily
Dietary supplement: Magnesium
Magnesium citrate / Magnesium oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood sampling
Time Frame: 6 weeks
measurement of stress metabolites
6 weeks
24h-urine
Time Frame: 6 weeks
measurement of stress metabolites
6 weeks
heart rate variability
Time Frame: 6 weeks
measurement of heart rate variability
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protina Pharmazeutische GmbH

Collaborators

Comenius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2017

Primary Completion (Actual)

June 6, 2017

Study Completion (Actual)

June 6, 2017

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • StressMag2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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