A Double-blind, Randomized Placebo-controlled Intervention Study About Possible Effects of the Dietary Supplement Magnesium.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,013
- Primary Endpoint
- Time x group difference in HealthWatch-11 (questionnaire)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Placebo
Placebo (rice powder), one pill daily for up to 3 months. Identical appearance as the magnesium pill.
Intervention: Placebo (Dietary Supplement)
Magnesium 375 mg
375 mg dietary supplement magnesium, one pill daily for up to 3 months.
Intervention: Magnesium (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Intervention compliance measure 2 (subjective, marked days in calendar)(From Baseline to the end of intervention at approximately 3 months.)
- Intervention compliance measure 1 (objective, number of pills left)(From Baseline to the end of intervention at approximately 3 months.)
Investigators
Dan Hasson
PhD, Associate Professor
Karolinska Institutet