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Micronutrient Supplement

MagnéVie B6® for Stress

N/A
Waitlist Available
Led By JESSIE HAWKINS, PhD
Research Sponsored by Franklin Health Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

Summary

This trial aims to see if a supplement with magnesium and vitamin B6 can reduce anxiety, stress, and burnout in nurses working full-time during the COVID-19 pandemic. The supplement is taken regularly over a period of weeks. Magnesium helps relax muscles and nerves, while vitamin B6 improves mood.

Eligible Conditions
  • Stress
  • Burnout

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
Number of participants with adverse events.
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.
Other study objectives
Cortisol awakening response after 8 weeks of intervention as compared to a control group after controlling for baseline scores.
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 DASS-42, MBI-HSS, and STAI after 4 weeks of intervention as compared to a control group, after controlling for baseline scores.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MagnéVie B6®Experimental Treatment1 Intervention
Each film coated tablet contains 100mg magnesium citrate and 10mg pyridoxine hydrochloride.
Group II: PlaceboPlacebo Group1 Intervention
Each identical film coated tablet contains inert materials.

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Who is running the clinical trial?

Opella Healthcare Group SAS (Sanofi Consumer Healthcare)UNKNOWN
Franklin Health ResearchLead Sponsor
16 Previous Clinical Trials
3,421 Total Patients Enrolled
Opella Healthcare Group SAS, a Sanofi CompanyIndustry Sponsor
3 Previous Clinical Trials
144 Total Patients Enrolled
~26 spots leftby Oct 2025
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