Burnout, ProfessionalNCT05363410
Micronutrient Supplement for Nurse Burnout
A study testing MagnéVie B6® in people with Burnout, Professional and Stress, Psychological, run by Nutraceuticals Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Stress, Psychological
- What is being tested?
- MagnéVie B6®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Franklin Health Research Center
Franklin, Tennessee, 37067
About this study
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
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.
Read the 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.
- Conditions
- Burnout, Professional, Stress, Psychological
- Being tested
- MagnéVie B6®, Placebo
- Medical subject headings
- Burnout, Professional, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnéVie B6®Dietary supplement
micronutrient supplement
PlaceboOther
placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| MagnéVie B6® | Experimental | Each film coated tablet contains 100mg magnesium citrate and 10mg pyridoxine hydrochloride. Receives: Dietary Supplement: MagnéVie B6® |
| Placebo | Placebo comparator | Each identical film coated tablet contains inert materials. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Number of participants with adverse events.
All AEs will be documented during the study, as they occur.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Opella Healthcare Group SAS, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- JESSIE HAWKINS, PhD, Principal investigator, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363410
- Sponsor's protocol ID
- 22-04-180
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05363410
- Acronym / sponsor ID
- 22-04-180
- Conditions
- Burnout, Professional, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Collaborators
- Opella Healthcare Group SAS, a Sanofi Company
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MagnéVie B6® | Experimental | Dietary Supplement: MagnéVie B6®Each film coated tablet contains 100mg magnesium citrate and 10mg pyridoxine hydrochloride. |
| Placebo | Placebo comparator | Other: PlaceboEach identical film coated tablet contains inert materials. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnéVie B6®micronutrient supplement | Dietary supplement | MagnéVie B6® |
| Placeboplacebo supplement | Other | Placebo |
Primary outcome
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.
Time frame: 8 weeks
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.
3 secondary outcomes
Scores on the State-Trait Anxiety Inventory after 8 weeks of intervention as compared to a control group, after controlling for baseline scores.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Number of participants with adverse events.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JESSIE HAWKINS, PhD principal investigator
Nutraceuticals Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagnéVie B6® in people with Burnout, Professional and Stress, Psychological, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JESSIE HAWKINS, PhD (6152613116, info@franklinhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.