NCT03203096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

June 22, 2017

Last Update Submit

June 26, 2017

Conditions

Stress Physiology

Keywords

magnesium, stress, metabolomics, heart rate variability

Outcome Measures

Primary Outcomes (3)

  • blood sampling

    measurement of stress metabolites

    6 weeks

  • 24h-urine

    measurement of stress metabolites

    6 weeks

  • heart rate variability

    measurement of heart rate variability

    6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

identically tasting and looking Placebo

Dietary Supplement: Placebo

Magnesium

ACTIVE COMPARATOR

Supplementation with 400 mg Magnesium from Magnesium Citrate / Magnesium Oxide once daily

Dietary Supplement: Magnesium

Interventions

MagnesiumDIETARY_SUPPLEMENT

Magnesium citrate / Magnesium oxide

Magnesium
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy students in exam preparation

You may not qualify if:

  • pregnancy
  • any chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomed Martin

Martin, 03601, Slovakia

Location

MeSH Terms

Interventions

Magnesium

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 29, 2017

Study Start

January 15, 2017

Primary Completion

June 6, 2017

Study Completion

June 6, 2017

Last Updated

June 29, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)