MagnéVie B6® for Stress, Psychological

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Franklin Health Research Center, Franklin, TN
Stress, Psychological+2 More
MagnéVie B6® - DietarySupplement
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

The purpose of this study is to confirm and quantify the ability of an 8-week intervention with a supplement containing magnesium citrate and vitamin B6 to reduce anxiety, stress, and burnout among nurses working full time in hospitals and urgent care centers during the COVID-19 Pandemic.

Eligible Conditions

  • Stress, Psychological
  • Burnout, Professional

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 8 weeks

4 weeks
Scores on the DASS-42, MBI-HSS, and STAI after 4 weeks of intervention as compared to a control group, after controlling for baseline scores.
8 weeks
Cortisol awakening response after 8 weeks of intervention as compared to a control group after controlling for baseline scores.
Number of participants with adverse events.
Scores on the DASS-42 total, anxiety, and depression sub-scores after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
Scores on the Depression Anxiety Stress Scale (DASS-42), stress sub-score after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
Scores on the Magnesium Deficiency Questionnaire (MDQ-62) after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
Scores on the Maslach Burnout Inventory for Health Personnel after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
Scores on the State-Trait Anxiety Inventory after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.

Trial Safety

Trial Design

2 Treatment Groups

MagnéVie B6®
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

88 Total Participants · 2 Treatment Groups

Primary Treatment: MagnéVie B6® · Has Placebo Group · N/A

MagnéVie B6®
DietarySupplement
Experimental Group · 1 Intervention: MagnéVie B6® · Intervention Types: DietarySupplement
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
Closest Location: Franklin Health Research Center · Franklin, TN
Photo of tennessee 1Photo of tennessee 2Photo of tennessee 3
2022First Recorded Clinical Trial
1 TrialsResearching Stress, Psychological
4 CompletedClinical Trials

Who is running the clinical trial?

Opella Healthcare Group SAS (Sanofi Consumer Healthcare)UNKNOWN
Franklin Health ResearchLead Sponsor
13 Previous Clinical Trials
3,163 Total Patients Enrolled
JESSIE HAWKINS, PhDPrincipal InvestigatorFranklin Health Research

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to comply with all study procedures and are available for the duration of the study.
You are employed as a nurse in a hospital, primary, or urgent care center that treats COVID-19 patients
You live in the United States.
You have a score of 22 or more on the Stress subscale of the DASS.
You are able to take oral medication and are willing to commit to taking 3 tablets a day for 8 weeks.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.