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PerimenopauseNCT07235878

12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being

A study testing Magnesium hydroxide 375mg in people with Perimenopause and Perimenopausal Women, run by Northumbria University at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Perimenopause is a transition phase into menopause, characterised by menopausal symptoms while menstrual periods are still occurring. Common symptoms of perimenopause include hot flushes, night sweats, mood swings, anxiety, sleep disturbances, fatigue, and cognitive difficulties. Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
What is being tested?
Magnesium hydroxide 375mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteUnited Kingdom
Study dates
9 Dec 2025to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Self-assess as healthy
  • Report experiencing troublesome peri-menopause symptoms in the past 6 months but not post-menopausal (defined as 12 months with no periods)

Who cannot join

  • Post-menopausal
  • Lactating, pregnant or seeking to become pregnant
  • Nut Allergy
  • Taken antidepressant/antianxiety medication or other medication with strong likelihood for effects on cognition or sleep in the past 6 months.
  • Habitual magnesium supplementation (defined as more than 3 consecutive days or 4 days in total). Will be excluded unless washout for 1 month.
  • Menopause symptoms have been medically induced.
  • Receiving gender-affirming hormone therapy.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • School of Psychology, Northumbria University

    Newcastle upon Tyne, NE1 8ST

Other trials in United Kingdom

About this study

Official title: Effects of 12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial

Perimenopause is a transition phase into menopause, characterised by menopausal symptoms while menstrual periods are still occurring. Common symptoms of perimenopause include hot flushes, night sweats, mood swings, anxiety, sleep disturbances, fatigue, and cognitive difficulties. These symptoms can be both frequent and intense, with the potential to significantly deteriorate women's quality of life. Despite an increase in public discourse around menopause, there are still large gaps in knowledge. Previous literature has suggested a relationship between diet and menopause management. However, studies in this area are limited and women often rely on social media for advice on supplements to address menopause complaints. One supplement that has received a lot of attention with purported benefits for menopause is magnesium, primarily due to its links to energy and or/sleep, however no studies have explored psychological effects of magnesium supplementation in perimenopause.

The aim of this study is to explore the effects of 12-weeks magnesium supplementation on perimenopause symptoms, cognition, sleep, and psychological well-being.

Read the detailed description

The term "perimenopause" describes a woman's life stage during which she undergoes changes due to hormone fluctuations but has not yet gone a full year without menstruation. It is a normal aspect of aging that typically affects women between the ages of 45 and 55, although some women may experience it sooner. While each person experiences symptoms differently, some common symptoms include irregular periods, hot flushes, night sweats, mood fluctuations, difficulty sleeping, decreased libido, vaginal dryness, memory and concentration problems. One widely recognised treatment for managing menopause symptoms is hormone replacement therapy (HRT). Although the benefits of HRT generally outweigh the risks, alternative options are needed for those with a history of breast cancer. Concerns surrounding risks have led many women to explore alternative approaches, including botanical and dietary supplements despite limited research on their efficacy and long-term effects. Women are increasingly turning to social media for advice on how to manage symptoms, and supplement manufacturers are beginning to target this audience with claims that they can reduce menopause symptoms. There is evidence of a link between nutrition and menopause, however research in this area is limited, especially in perimenopause. Magnesium is commonly promoted as a treatment for menopause symptoms, and there is some evidence that it improves sleep and overall well-being, but no research has looked into its effects in perimenopause. This study aims to examine the effects of 12-week magnesium hydroxide supplementation on cognition, sleep and psychological well-being in peri-menopausal women, with the results compared with those of a placebo.

Being tested
Placebo, Magnesium hydroxide 375mg
Keywords
perimenopause, cognition, psychological wellbeing, sleep, magnesium, memory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    12 week placebo supplement of 2 capsules per day

  • Magnesium hydroxide 375mgDietary supplement

    12 week supplementation of 2 capsules per day of Magnesium hydroxide

Study groups in NCT07235878
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo capsule consumed for 84 days
Receives: Other: Placebo
375mg magnesium hydroxideExperimentalMagnesium hydroxide capsule consumed for 84 days
Receives: Dietary Supplement: Magnesium hydroxide 375mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric working memory task % accuracy

    Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  2. Numeric working memory task reaction time

    Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  3. 3-back task % accuracy

    Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  4. 3-Back task reaction time

    Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  5. Corsi blocks task score

    Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  6. Alphabetic working memory task % accuracy

    Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  7. Alphabetic working memory task reaction time

    Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  8. Word recognition % accuracy

    Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  9. Word recognition reaction time

    Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  10. Picture recognition % accuracy

    Cognitive function - episodic memory task. Measured as a percentage, with a higher score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  11. Picture recognition reaction time

    Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

Secondary outcomes (7)
  1. The Menopause-Specific Quality of Life Questionnaire (Hilditch, 1996)

    Assesses the effect of menopausal symptoms on quality of life in four domains: vasomotor, psychosocial, physical, and sexual; as well as providing a total score. The questionnaire has 29 items, each item is a symptom of menopause, the participants rate each symptom between 0 (not at all bothered) to 6 (bothered all the time.) The vasomotor symptoms include items such as 'hot flushes' and 'sweating'; psychological symptoms include 'accomplishing less than I used to' and 'poor memory'; physical symptoms include 'difficulty sleeping' and 'weight gain'; sexual symptoms include 'vaginal dryness' and 'avoiding intimacy'. A conversion score is created for each of the 4 domains: vasomotor; psychosocial; physical; sexual; as well as a total score. Each score ranges from 1 -8, with higher scores indicating greater problems.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  2. Centre for Epidemiologic Studies Depression Scale (Radlof, 1997)

    This is an established questionnaire used to measure symptoms associated with depression. The questionnaire has 20 items, including 'my sleep is restless', 'I felt depressed' and 'I felt lonely'. The participants rate the symptom on a scale between <1 day and 5 to 7 days, the 4 scale points are: Rarely or none of the time (less than 1 day); Some or a little of the time (1-2 days); Occasionally or a moderate amount of time (3-4 days); Most or all of the time (5-7 days). The possible range of scores is between 0 to 60, higher scores indicate more presence of symptomatology. The scoring of positive items is reversed.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  3. The State-Trait Anxiety Inventory, TRAIT subscale (Spielberger, 1983)

    The state-trait anxiety inventory will be used to measure anxiety levels, specifically trait anxiety. It consists of 20 items and the scale ranges from 1 to 4: 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always. The nine positive items will be reversed for scoring, items 21, 23, 26, 27, 30, 33, 34, 36 and 39. The possible range of scores is 20 to 80, higher scores indicate higher levels of trait anxiety within the participant. Examples of items within the questionnaire include: 'I feel like a failure' and 'I feel secure'.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  4. The Perceived Stress Scale (Cohen et al., 1983)

    This established questionnaire will be used to measure the perception of stress. Each of the ten items are rated on a scale between 0 (never) to 4 (very often.) The five scale points are 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often. The four positive items will be reversed for scoring, items 4, 5, 7 and 8. The questionnaire item examples include 'In the last month, how often have you been upset because of something that happened unexpectedly?' and 'In the last month, how often have you felt that you were unable to control the important things in your life?'. The possible range of scores is between 0 to 40, higher scores indicate high participant perceived stress.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  5. Visual Analogue Mood Scales (VAMS)

    This is a series of mood scales. Each scale is a line anchored at either side by an adjective describing a mood. Participants must click at a point on the scale that represents how they are feeling at that point in time. There are 18 scales in total, each scored out of 100. From these scales three composite scores are calculated describing feelings of 'Alertness', 'Stress' and 'Tranquillity', which are also presented as a score out of 100.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  6. Sleep Related Impairment (PROMIS-SRI) (Yu et al., 2011)

    The PROMIS-SRI will be used to measure sleep related impairment. The questionnaire contains 8 items, and participants are required to answer in relation to their sleep within the past 7 days. Each item is rated on a scale from 1-5. The items are then summed to create a single value (range 8-40), with higher scores indicating higher levels of sleep disturbance. Examples of items within the questionnaire include: 'I felt alert when I woke up' and 'I had a hard time getting things done because I was sleepy'.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

  7. Sleep Disturbance (PROMIS-SD) (Yu et al., 2011)

    The PROMIS-SD will be used to measure sleep disturbance. The questionnaire contains 8 items, and participants are required to answer in relation to their sleep within the past 7 days. Each item is rated on a scale from 1-5. The items are then summed to create a single value (range 8-40), with higher scores indicating higher levels of sleep disturbance. Examples of items within the questionnaire include: 'my sleep was restless' and 'I had difficulty falling asleep'.

    Measured: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start9 Dec 2025
  3. Primary completion18 Oct 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Active vs. placebo
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235878
Sponsor's protocol ID
10251
Status last verified
Apr 2026
First submitted
17 Sep 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: An anonymised dataset will be shared on this platform within the results section. Any information which may identify individual participants will be removed from the dataset before it is shared. Data will be shared in accordance with FAIR (findable, accessible, interoperable, reusable) principles. Participants will consent to the data being shared in this way.

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium hydroxide 375mg in people with Perimenopause and Perimenopausal Women, run by Northumbria University at 1 site in United Kingdom.

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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. 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 Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

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?

Numeric working memory task % accuracy (time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.). The study lists 11 primary outcomes in all. 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 Aug 2026.

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