Micronutrient Supplement for Nurse Burnout

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Burnout, Professional, Stress, Psychological

Intervention / Treatment
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* Dietary Supplement: MagnéVie B6®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |