Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332248
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2024-03-12
Brief Title:
Possible Effects of the Dietary Supplement Magnesium Compared to Placebo
Sponsor:
Dan Hasson
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Intervention Study About Possible Effects of the Dietary Supplement Magnesium
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 headachemigraine 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 pressuremetabolic syndrome
Magnesium is one of the bodys 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 eg 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 magnesiumplacebo both or none of them
Individuals enrolled in the magnesiumplacebo 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 magnesiumplacebo 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 magnesiumplacebo kit and the compliance calendar
Previous research studies have shown that magnesium has promising effects to counteract or mitigate for instance headachemigraine 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 pressuremetabolic syndrome
Magnesium is one of the bodys 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 eg 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 magnesiumplacebo both or none of them
Individuals enrolled in the magnesiumplacebo 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 magnesiumplacebo 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 magnesiumplacebo kit and the compliance calendar
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None