Status:
UNKNOWN
Micronutrient Supplement for Nurse Burnout
Lead Sponsor:
Nutraceuticals Research Institute
Collaborating Sponsors:
Opella Healthcare Group SAS, a Sanofi Company
Conditions:
Burnout, Professional
Stress, Psychological
Eligibility:
FEMALE
20-59 years
Phase:
NA
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 nu...
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 eithe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05363410
Start Date
May 1 2022
End Date
April 30 2023
Last Update
May 5 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Franklin Health Research Center
Franklin, Tennessee, United States, 37067