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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
Awards & highlights

Study Summary

This trial will test whether magnesium citrate + B6 can help reduce stress, anxiety, and burnout in full-time hospital nurses during the COVID-19 pandemic.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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
15 Previous Clinical Trials
3,368 Total Patients Enrolled
Opella Healthcare Group SAS, a Sanofi CompanyIndustry Sponsor
2 Previous Clinical Trials
119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for participation in this clinical investigation?

"This clinical trial has stipulated that only those aged 20 to 59 are eligible. Additionally, there are 37 trials specifically for minors and 141 studies targeting seniors."

Answered by AI

Are there openings available to enroll in this clinical trial?

"As evidenced on clinicaltrials.gov's listings, this experiment is no longer open to recruitment. It was originally posted on the first of May 2022 and last updated three days later; however, 175 other trials are still actively accepting patients at this time."

Answered by AI

Who is able to partake in this investigative endeavor?

"This investigation is enrolling eighty-eight female volunteers aged 20 to 59 suffering from psychological stress. Candidates must meet the following qualifications: exhibit good general health, provide informed consent and agree to abide by trial procedures throughout, be employed full time (35 hours or more a week) as an oncology nurse in a COVID-19 treatment facility, comply with lifestyle considerations for duration of study, live within the USA borders, have DASS Stress subscale score above 22 points; ability to swallow oral medication and agreement to take three tablets daily during 8 weeks period."

Answered by AI
~31 spots leftby Mar 2025