Stress PhysiologyNCT03203096
Magnesium Supplementation in Stress Conditions
A study testing Magnesium in people with Stress Physiology, run by Protina Pharmazeutische GmbH at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Physiology
- What is being tested?
- Magnesium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Jan 2017to 6 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy students in exam preparation
Who cannot join
- pregnancy
- any chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stress Physiology
- Being tested
- Magnesium, Placebo
- Keywords
- magnesium, stress, metabolomics, heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDietary supplement
Magnesium citrate / Magnesium oxide
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | identically tasting and looking Placebo Receives: Dietary Supplement: Placebo |
| Magnesium | Active comparator | Supplementation with 400 mg Magnesium from Magnesium Citrate / Magnesium Oxide once daily Receives: Dietary Supplement: Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sampling
measurement of stress metabolites
Measured: 6 weeks
24h-urine
measurement of stress metabolites
Measured: 6 weeks
heart rate variability
measurement of heart rate variability
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start15 Jan 2017
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protina Pharmazeutische GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Comenius University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203096
- Sponsor's protocol ID
- StressMag2017
- Status last verified
- Jun 2017
- First submitted
- 22 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03203096
- Acronym / sponsor ID
- StressMag2017
- Conditions
- Stress Physiology
- Keywords
- magnesium, stress, metabolomics, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Protina Pharmazeutische GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Comenius University
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboidentically tasting and looking Placebo |
| Magnesium | Active comparator | Dietary Supplement: MagnesiumSupplementation with 400 mg Magnesium from Magnesium Citrate / Magnesium Oxide once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy students in exam preparation
Key exclusion criteria (2 listed)
- pregnancy
- any chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnesiumMagnesium citrate / Magnesium oxide | Dietary supplement | Magnesium |
| Placebo | Dietary supplement | Placebo |
Primary outcome
blood sampling
Time frame: 6 weeks
measurement of stress metabolites
24h-urine
Time frame: 6 weeks
measurement of stress metabolites
heart rate variability
Time frame: 6 weeks
measurement of heart rate variability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium in people with Stress Physiology, run by Protina Pharmazeutische GmbH at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sampling (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.