Micronutrient Supplement for Nurse Burnout

Franklin Health Research

Status: Unknown

Conditions: Burnout, Professional; Stress, Psychological

Treatments: Other: Placebo; Dietary Supplement: MagnéVie B6®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05363410

22-04-180

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: Female

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

MagnéVie B6®

Experimental group

Description:

Each film coated tablet contains 100mg magnesium citrate and 10mg pyridoxine hydrochloride.

Treatment:

Dietary Supplement: MagnéVie B6®

Placebo

Placebo Comparator group

Description:

Each identical film coated tablet contains inert materials.

Treatment:

Other: Placebo