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| Name | Class |
|---|---|
| Opella Healthcare Group SAS, a Sanofi Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MagnéVie B6® | Experimental | Each film coated tablet contains 100mg magnesium citrate and 10mg pyridoxine hydrochloride. |
|
| Placebo | Placebo Comparator | Each identical film coated tablet contains inert materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagnéVie B6® | Dietary Supplement | micronutrient supplement |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
self representation of gender identity
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JESSIE HAWKINS, PhD | Contact | 6152613116 | info@franklinhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| JESSIE HAWKINS, PhD | Nutraceuticals Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin Health Research Center | Franklin | Tennessee | 37067 | United States |
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| ID | Term |
|---|---|
| D002055 | Burnout, Professional |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D000073397 | Occupational Stress |
| D009784 | Occupational Diseases |
| D000077062 | Burnout, Psychological |
| D001526 | Behavioral Symptoms |
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| Placebo |
| Other |
placebo supplement |
|
| 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 |
| 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 |
| 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 |
| 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 |
| D001519 | Behavior |