Micronutrient Supplement for Nurse Burnout

Quantifying the Effects of MagnéVie B6® on Stress and Burnout Among Nurses During the COVID-19 Pandemic: A Randomized Double Blind Placebo-Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burnout, Professional; Stress, Psychological
• Intervention / Treatment: Dietary supplement: MagnéVie B6®; Other: Placebo

Detailed Description

After being informed about the study and potential risks, all participants woh meet the eligibility criteria will provide written informed consent. They will then be randomized in a 1:1 ratio to either MagnéVie B6® or a placebo group. The assigned product will be consumed 3 times daily for 8 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JESSIE HAWKINS, PhD; Phone Number: 6152613116; Email: info@franklinhealth.org

Study Locations

• United States
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin Health Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Woman aged 20-59
• Lives in the United States
• In good general health as evidenced by medical history
• Stress subscale score from the DASS > =22
• Ability to take oral medication and be willing to commit to taking 3 tablets a day for 8 weeks.
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of MagnéVie B6® administration
• Employed full time as a nurse in a hospital, primary, or urgent care center that treats COVID-19 patients. Full time is defined as 35 hours or more each week.
• Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

• Current use of the following pharmaceuticals: bisphosphonates, calcium channel blockers, digoxin, aminoglycoside antibiotics, ketamine, levodopa/carbidopa, gabapentin, potassium sparing diuretics, quinolone antibiotics, skeletal muscle relaxants, sulfonylureas, tetracycline antibiotics, amiodarone, antihypertensives, or antiepileptic drugs (including phenytoin, valproic acid, carbamazepine, phenobarbital).
• Pregnancy, trying to conceive or breastfeeding
• Known allergic reactions to any components of the supplement including magnesium citrate anhydrous, pyridoxine hydrochloride, lactose anhydrous, magnesium stearate, hypromellose, macrogol 6000 titanium dioxide, or talc
• Positive COVID-19 test within 60 days of the study period
• COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study
• Current diagnosis or lifetime history of a bleeding disorder, kidney disease, or neuromuscular disease
• Recent dramatic weight changes (10% change in body weight in the last 6 months)
• Existing usage of a magnesium or vitamin B6 supplement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MagnéVie B6®; Each film coated tablet contains 100mg magnesium citrate and 10mg pyridoxine hydrochloride.	Dietary supplement: MagnéVie B6®; micronutrient supplement
Placebo Comparator: Placebo; Each identical film coated tablet contains inert materials.	Other: Placebo; placebo supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The Depression Anxiety Stress Scale (DASS) 42 is a validated self report measure assessing depression, stress, and anxiety. The scale includes 42 total questions with 14 in each subscale. Higher scores indicate higher severity.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on the State-Trait Anxiety Inventory after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.	The STAI is a validated, self reporting instrument assessing anxiety. Possible scores range from 20-80 with higher scores indicating lower quality wellbeing. The instrument contains 40 items.	8 weeks
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.	The Maslach Burnout Inventory for Health Personnel measures the impact of stress specifically among healthcare professionals. It includes emotional exhaustion, loss of feeling towards patients, and the loss of feelings of competence and accomplishment in work. Items are scored on a 1-7 scale and combined by domain, with higher scores indicating greater levels of burnout.	8 weeks
Number of participants with adverse events.	All AEs will be documented during the study, as they occur.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The Depression Anxiety Stress Scale (DASS) 42 is a validated self report measure assessing depression, stress, and anxiety. The scale includes 42 total questions with 14 in each subscale. Higher scores indicate higher severity.	8 weeks
Scores on the Magnesium Deficiency Questionnaire (MDQ-62) after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.	The MDQ-62 contains 62 self report items which assess magnesium deficiency symptoms in the body. Higher scores indicate a greater probability of magnesium deficiency.	8 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.	The Depression Anxiety Stress Scale (DASS) 42 is a validated self report measure assessing depression, stress, and anxiety. The scale includes 42 total questions with 14 in each subscale. Higher scores indicate higher severity.	4 weeks
Cortisol awakening response after 8 weeks of intervention as compared to a control group after controlling for baseline scores.	Salivary cortisol samples will be collected to measure the awakening response. This includes cortisol samples immediately after waking, followed by 30 minutes after waking, for 2 consecutive days. This will be done at baseline and posttest.	8 weeks

Collaborators and Investigators

• Sponsor: Franklin Health Research
• Collaborators: Opella Healthcare Group SAS, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Occupational Stress; Occupational Diseases; Burnout, Professional; Burnout, Psychological; Stress, Psychological
• Other Study ID Numbers: 22-04-180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No