Health PromotionNCT06332248
Possible Effects of the Dietary Supplement Magnesium Compared to Placebo
A study testing Magnesium in people with Health Promotion, run by Dan Hasson.
Trial summary
The goal of this clinical trial was to investigate possible outcomes of the nutritional supplement magnesium compared to placebo in healthy, working adults. The main questions it aimed to answer were: Are there differences in ratings of health, stress, well-being and work environment indicators between individuals… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,013 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2014to 28 May 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals employed at the participating organizations (21 schools and one white collar organization) who provided their informed consent and were at least 18 years old.
Who cannot join
- Individuals with creatinine levels more than195 μmol/L for women and more than 230 μmol/L for men.
- Individuals who had undergone a liver transplant.
- Lithium intake or prescription.
- Pregnant women were disadvised from participation.
About this study
Official title: A Double-blind, Randomized Placebo-controlled Intervention Study About Possible Effects of the Dietary Supplement Magnesium.
The goal of this clinical trial was to investigate possible outcomes of the nutritional supplement magnesium compared to placebo in healthy, working adults. The main questions it aimed to answer were:
- Are there differences in ratings of health, stress, well-being and work environment indicators between individuals intaking 375 mg magnesium (daily for 3 months) compared to placebo?
- Are there differences in hearing, measured with hearing tests between those receiving 375 mg magnesium compared to placebo?
Read more
Participants were asked to ingest 375 mg magnesium or placebo daily for 3 months.
Researchers compared the group ingesting magnesium with the group ingesting placebo pills to see if there were any differences in for example self-rated health, recovery, wellbeing, etc.
Read the detailed description
Summary: The aim of the sub-study was to investigate possible beneficial effects of magnesium as a nutritional supplement regarding self-reported health, ill-health, pain, hearing, fatigue, signs of long term stress and more. The study was designed as a double-blind placebo-randomized controlled study, meaning that each enrolled individual was randomized to either 375 mg magnesium or placebo pills. Clinical hearing tests, blood pressure, pulse and creatinine were conducted and collected. Extensive questionnaires were distributed at baseline (T1) and after approximately 3 months (T2) of daily pill intake in order to evaluate possible effects. All participants were adults and healthy enough to work.
Previous research studies have shown that magnesium has promising effects to counteract or mitigate for instance headache/migraine, muscle cramps, high blood pressure, asthma as well as hearing problems such as tinnitus and sound sensitivity (hyperacusis). Magnesium deficiency is related to reduced immune function and physical symptoms such as migraine, muscle cramps, osteoporosis and high blood pressure/metabolic syndrome.
Magnesium is one of the body's most common and important minerals. It is involved in the regulation of the nerve activity and the muscle function. As a dietary supplement, it is affordable, easily administrated and safe. Adverse effects in the form of diarrhea can occur if magnesium is greatly overdosed. The participants in this trial were informed about this and possible other adverse effects and were recommended to terminate participation or decrease the intake (e.g., take half a pill) in case of any experienced adverse effects. They were also encouraged to report any adverse effects immediately.
The primary objective with the study was to investigate if there were differences between the treatment group (magnesium) and the control group (placebo) over time in health-related outcomes, recovery and well-being.
The present study was conducted as a separate study within a larger intervention study for employees at 21 schools in Stockholm, Sweden. The purpose of the larger intervention study was to evaluate possible effects of systematic interventions for health promotion and work environment improvements, as well as to counteract harmful stress and long-term sick-leave.
Employees could choose to participate in the larger intervention study, the sub study about magnesium/placebo, both or none of them.
Individuals enrolled in the magnesium/placebo randomized control trial by signing up for a session of hearing tests and other physiological measures approximately one week before the session. The researchers randomized each enrolled individual and prepared a kit containing the randomized jar of pills (magnesium or placebo), a paper adherence calendar, general information about the study along with instructions for intake and a protocol used by the researchers during the session. In some cases, there were some last-minute enrollments who were randomized onsite. During the session (at the participants workplace), hearing tests were performed with portable equipment, and measures of blood pressure, pulse and creatinine were performed. At the end of the session, the participant was provided with the magnesium/placebo kit and was asked to fill out a web-based questionnaire. The same measures were performed after approximately three months, except for the creatinine test. Participants were also asked to fill out another web-based questionnaire and were asked to return the magnesium/placebo kit and the compliance calendar.
- Conditions
- Health Promotion
- Being tested
- Magnesium, Placebo
- Keywords
- Self-rated health, Stress, Magnesium supplement, Placebo, Double-blind, Randomized controlled trial (RCT), Wellbeing, Recovery, Stress management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDietary supplement
The dietary supplement magnesium (375 mg) was given daily for up to 3 months (oral intake).
PlaceboDietary supplement
Placebo tablet, oral intake once a day for up to three months.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium 375 mg | Experimental | 375 mg dietary supplement magnesium, one pill daily for up to 3 months. Receives: Dietary Supplement: Magnesium |
| Placebo | Placebo comparator | Placebo (rice powder), one pill daily for up to 3 months. Identical appearance as the magnesium pill. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time x group difference in HealthWatch-11 (questionnaire)
The questionnaire HealthWatch-11 (HW-11) was utilized with all 11 items: self-rated health, sleep, concentration ability, stress, energy level, control, social support, work efficiency, job satisfaction, workload and work atmosphere. Scale type is verbal rating scale (VRS) for all items (stress and work efficiency use visual analogue scale). The minimum value is 0 and the maximum value is 100 for all items. Higher values mean better outcomes for all variables except for stress and workload, where lower values are better and higher values are worse.
Measured: From Baseline to the end of intervention at approximately 3 months.
Secondary outcomes (2)
Intervention compliance measure 1 (objective, number of pills left)
Compliance in the intervention was assessed by counting the number of pills left in the jar. Each jar contained 100 pills at baseline.
Measured: From Baseline to the end of intervention at approximately 3 months.
Intervention compliance measure 2 (subjective, marked days in calendar)
Compliance in the intervention was assessed by counting the number of marked days in the compliance calendar.
Measured: From Baseline to the end of intervention at approximately 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start15 Sep 2014
- Primary completion20 May 2015
- Study completion28 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants received either 375 mg nutritional supplement magnesium or placebo pill.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Hasson
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Stressmottagningen, AFA Insurance
- Responsible party
- Sponsor-investigator, Dan Hasson, Karolinska Institutet
- Investigators
- Dan Hasson, PhD, Principal investigator, Karolinska Institutet and Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332248
- Sponsor's protocol ID
- 2014/1023-31/4 & 2014/274-31/5
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Placebo-controlled Intervention Study About Possible Effects of the Dietary Supplement Magnesium.
- ClinicalTrials.gov ID
- NCT06332248
- Acronym / sponsor ID
- 2014/1023-31/4 & 2014/274-31/5
- Conditions
- Health Promotion
- Keywords
- Self-rated health, Stress, Magnesium supplement, Placebo, Double-blind, Randomized controlled trial (RCT), Wellbeing, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- Dan HassonUniversity, hospital or other
- Collaborators
- Stiftelsen Stressmottagningen, AFA Insurance
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 20 May 2015 (actual)
- Study completion
- 28 May 2015 (actual)
- First posted
- 27 Mar 2024 (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 goal of this clinical trial was to investigate possible outcomes of the nutritional supplement magnesium compared to placebo in healthy, working adults. The main questions it aimed to answer were:
- Are there differences in ratings of health, stress, well-being and work environment indicators between individuals intaking 375 mg magnesium (daily for 3 months) compared to placebo?
- Are there differences in hearing, measured with hearing tests between those receiving 375 mg magnesium compared to placebo?
Participants were asked to ingest 375 mg magnesium or placebo daily for 3 months.
Researchers compared the group ingesting magnesium with the group ingesting placebo pills to see if there were any differences in for example self-rated health, recovery, wellbeing, etc.
Detailed description
Summary: The aim of the sub-study was to investigate possible beneficial effects of magnesium as a nutritional supplement regarding self-reported health, ill-health, pain, hearing, fatigue, signs of long term stress and more. The study was designed as a double-blind placebo-randomized controlled study, meaning that each enrolled individual was randomized to either 375 mg magnesium or placebo pills. Clinical hearing tests, blood pressure, pulse and creatinine were conducted and collected. Extensive questionnaires were distributed at baseline (T1) and after approximately 3 months (T2) of daily pill intake in order to evaluate possible effects. All participants were adults and healthy enough to work.
Previous research studies have shown that magnesium has promising effects to counteract or mitigate for instance headache/migraine, muscle cramps, high blood pressure, asthma as well as hearing problems such as tinnitus and sound sensitivity (hyperacusis). Magnesium deficiency is related to reduced immune function and physical symptoms such as migraine, muscle cramps, osteoporosis and high blood pressure/metabolic syndrome.
Magnesium is one of the body's most common and important minerals. It is involved in the regulation of the nerve activity and the muscle function. As a dietary supplement, it is affordable, easily administrated and safe. Adverse effects in the form of diarrhea can occur if magnesium is greatly overdosed. The participants in this trial were informed about this and possible other adverse effects and were recommended to terminate participation or decrease the intake (e.g., take half a pill) in case of any experienced adverse effects. They were also encouraged to report any adverse effects immediately.
The primary objective with the study was to investigate if there were differences between the treatment group (magnesium) and the control group (placebo) over time in health-related outcomes, recovery and well-being.
The present study was conducted as a separate study within a larger intervention study for employees at 21 schools in Stockholm, Sweden. The purpose of the larger intervention study was to evaluate possible effects of systematic interventions for health promotion and work environment improvements, as well as to counteract harmful stress and long-term sick-leave.
Employees could choose to participate in the larger intervention study, the sub study about magnesium/placebo, both or none of them.
Individuals enrolled in the magnesium/placebo randomized control trial by signing up for a session of hearing tests and other physiological measures approximately one week before the session. The researchers randomized each enrolled individual and prepared a kit containing the randomized jar of pills (magnesium or placebo), a paper adherence calendar, general information about the study along with instructions for intake and a protocol used by the researchers during the session. In some cases, there were some last-minute enrollments who were randomized onsite. During the session (at the participants workplace), hearing tests were performed with portable equipment, and measures of blood pressure, pulse and creatinine were performed. At the end of the session, the participant was provided with the magnesium/placebo kit and was asked to fill out a web-based questionnaire. The same measures were performed after approximately three months, except for the creatinine test. Participants were also asked to fill out another web-based questionnaire and were asked to return the magnesium/placebo kit and the compliance calendar.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants received either 375 mg nutritional supplement magnesium or placebo pill.
| Arm | Type | Receives |
|---|---|---|
| Magnesium 375 mg | Experimental | Dietary Supplement: Magnesium375 mg dietary supplement magnesium, one pill daily for up to 3 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (rice powder), one pill daily for up to 3 months. Identical appearance as the magnesium pill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals employed at the participating organizations (21 schools and one white collar organization) who provided their informed consent and were at least 18 years old.
Key exclusion criteria (4 listed)
- Individuals with creatinine levels more than195 μmol/L for women and more than 230 μmol/L for men.
- Individuals who had undergone a liver transplant.
- Lithium intake or prescription.
- Pregnant women were disadvised from participation.
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 |
|---|---|---|
| MagnesiumThe dietary supplement magnesium (375 mg) was given daily for up to 3 months (oral intake). | Dietary supplement | Magnesium 375 mg |
| PlaceboPlacebo tablet, oral intake once a day for up to three months. | Dietary supplement | Placebo |
Primary outcome
Time x group difference in HealthWatch-11 (questionnaire)
Time frame: From Baseline to the end of intervention at approximately 3 months.
The questionnaire HealthWatch-11 (HW-11) was utilized with all 11 items: self-rated health, sleep, concentration ability, stress, energy level, control, social support, work efficiency, job satisfaction, workload and work atmosphere. Scale type is verbal rating scale (VRS) for all items (stress and work efficiency use visual analogue scale). The minimum value is 0 and the maximum value is 100 for all items. Higher values mean better outcomes for all variables except for stress and workload, where lower values are better and higher values are worse.
2 secondary outcomes
Intervention compliance measure 1 (objective, number of pills left)
Time frame: From Baseline to the end of intervention at approximately 3 months.
Intervention compliance measure 2 (subjective, marked days in calendar)
Time frame: From Baseline to the end of intervention at approximately 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- 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.
Dan Hasson, PhD principal investigator
Karolinska Institutet and Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium in people with Health Promotion, run by Dan Hasson.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time x group difference in HealthWatch-11 (questionnaire) (time frame: From Baseline to the end of intervention at approximately 3 months.). 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 27 Mar 2024.