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Micronutrient Supplement for Nurse Burnout

Primary Purpose

Burnout, Professional, Stress, Psychological

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MagnéVie B6®
Placebo
Sponsored by
Franklin Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burnout, Professional

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Franklin Health Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MagnéVie B6®

Placebo

Arm Description

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

Each identical film coated tablet contains inert materials.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of participants with adverse events.
All AEs will be documented during the study, as they occur.

Full Information

First Posted
April 29, 2022
Last Updated
May 3, 2022
Sponsor
Franklin Health Research
Collaborators
Opella Healthcare Group SAS, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT05363410
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franklin Health Research
Collaborators
Opella Healthcare Group SAS, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MagnéVie B6®
Arm Type
Experimental
Arm Description
Each film coated tablet contains 100mg magnesium citrate and 10mg pyridoxine hydrochloride.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each identical film coated tablet contains inert materials.
Intervention Type
Dietary Supplement
Intervention Name(s)
MagnéVie B6®
Intervention Description
micronutrient supplement
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo supplement
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Scores on the State-Trait Anxiety Inventory after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
Description
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.
Time Frame
8 weeks
Title
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.
Description
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.
Time Frame
8 weeks
Title
Number of participants with adverse events.
Description
All AEs will be documented during the study, as they occur.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
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.
Description
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.
Time Frame
8 weeks
Title
Scores on the Magnesium Deficiency Questionnaire (MDQ-62) after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
Description
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.
Time Frame
8 weeks
Title
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.
Description
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.
Time Frame
4 weeks
Title
Cortisol awakening response after 8 weeks of intervention as compared to a control group after controlling for baseline scores.
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self representation of gender identity
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JESSIE HAWKINS, PhD
Phone
6152613116
Email
info@franklinhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JESSIE HAWKINS, PhD
Organizational Affiliation
Franklin Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franklin Health Research Center
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Micronutrient Supplement for Nurse Burnout

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