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Trial record 11 of 1643 for:    Slovakia

Magnesium Supplementation in Stress Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203096
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Collaborator:
Comenius University
Information provided by (Responsible Party):
Protina Pharmazeutische GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Stress Physiology Dietary Supplement: Magnesium Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : June 6, 2017
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. blood sampling [ Time Frame: 6 weeks ]
    measurement of stress metabolites

  2. 24h-urine [ Time Frame: 6 weeks ]
    measurement of stress metabolites

  3. heart rate variability [ Time Frame: 6 weeks ]
    measurement of heart rate variability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy students in exam preparation

Exclusion Criteria:

  • pregnancy
  • any chronic diseases

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): NCT03203096


Locations
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Slovakia
Biomed Martin
Martin, Slovakia, 03601
Sponsors and Collaborators
Protina Pharmazeutische GmbH
Comenius University

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Responsible Party: Protina Pharmazeutische GmbH
ClinicalTrials.gov Identifier: NCT03203096     History of Changes
Other Study ID Numbers: StressMag2017
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Protina Pharmazeutische GmbH:
magnesium, stress, metabolomics, heart rate variability
Additional relevant MeSH terms:
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Magnesium citrate
Magnesium Oxide
Cathartics
Gastrointestinal Agents
Antacids
Molecular Mechanisms of Pharmacological Action