Clinical trial NCT05363410: Micronutrient Supplement for Nurse Burnout
Official title: Quantifying the Effects of MagnéVie B6® on Stress and Burnout Among Nurses During the COVID-19 Pandemic: A Randomized Double Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burnout, Professional
Stress, Psychological
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
Collaborators: name: Opella Healthcare Group SAS, a Sanofi Company
First posted: 2022-05-05
Enrollment: 88
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 8 weeks
Secondary outcomes:
measure: Scores on the State-Trait Anxiety Inventory after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: Number of participants with adverse events.
timeFrame: 8 weeks
Other outcomes:
measure: 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.
timeFrame: 8 weeks
measure: Scores on the Magnesium Deficiency Questionnaire (MDQ-62) after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
timeFrame: 8 weeks
measure: 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.
timeFrame: 4 weeks
measure: Cortisol awakening response after 8 weeks of intervention as compared to a control group after controlling for baseline scores.
timeFrame: 8 weeks
Locations:
city: Franklin
country: United States
facility: Franklin Health Research Center
state: Tennessee
Study officials:
affiliation: Nutraceuticals Research Institute
name: JESSIE HAWKINS, PhD
role: PRINCIPAL_INVESTIGATOR
References: