Possible Effects of the Dietary Supplement Magnesium Compared to Placebo

NCT06332248 | Completed

• 1 other identifier: 2014/1023-31/4 & 2014/274-31/5
• Study Type: interventional
• Target: 1,013
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Health Promotion

Keywords

Self-rated health; Stress; Magnesium supplement; Placebo; Double-blind; Randomized controlled trial (RCT); Wellbeing; Recovery; Stress management

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to the end of intervention at approximately 3 months.

Secondary Outcomes (2)

• Intervention compliance measure 1 (objective, number of pills left)

  From Baseline to the end of intervention at approximately 3 months.

• Intervention compliance measure 2 (subjective, marked days in calendar)

  From Baseline to the end of intervention at approximately 3 months.

Other Outcomes (12)

• Time x group difference in Oldenburg Burnout Inventory (questionnaire)

  From Baseline to the end of intervention at approximately 3 months.

• Time x group difference in Karolinska Sleep Questionnaire

  From Baseline to the end of intervention at approximately 3 months.

• Time x group difference in Pure Tone Audiogram (clinical hearing test)

  From Baseline to the end of intervention at approximately 3 months.

Study Arms (2)

Magnesium 375 mg

EXPERIMENTAL

375 mg dietary supplement magnesium, one pill daily for up to 3 months.

Dietary Supplement: Magnesium

Placebo

PLACEBO COMPARATOR

Placebo (rice powder), one pill daily for up to 3 months. Identical appearance as the magnesium pill.

Dietary Supplement: Placebo

Interventions

Magnesium DIETARY_SUPPLEMENT

The dietary supplement magnesium (375 mg) was given daily for up to 3 months (oral intake).

Magnesium 375 mg

Placebo DIETARY_SUPPLEMENT

Placebo tablet, oral intake once a day for up to three months.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dan Hasson: lead
• Stiftelsen Stressmottagningen: collaborator
• AFA Insurance: collaborator

MeSH Terms

Interventions

Magnesium

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Dan Hasson, PhD

  Karolinska Institutet and Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Associate Professor

Model Details: Participants received either 375 mg nutritional supplement magnesium or placebo pill.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 27, 2024
• Study Start: September 15, 2014
• Primary Completion: May 20, 2015
• Study Completion: May 28, 2015
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share