Micronutrient Supplement for Nurse Burnout

Stress, Psychological Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05363410
• Other study ID #: 22-04-180
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2022
• Source: Franklin Health Research
• Contact: JESSIE HAWKINS, PhD
• Phone: 6152613116
• Email: info[@]franklinhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: April 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• Stress, Psychological

Intervention

Dietary Supplement:
• MagnéVie B6®
micronutrient supplement

Other:
• Placebo
placebo supplement

Locations

Country	Name	City	State
United States	Franklin Health Research Center	Franklin	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Franklin Health Research	Opella Healthcare Group SAS (Sanofi Consumer Healthcare)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	Number of participants with adverse events.	All AEs will be documented during the study, as they occur.	8 weeks