Status:
NOT_YET_RECRUITING
Magnesium-L-Threonate Improves Menopausal Symptoms
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Menopause Syndrome
Magnesium
Eligibility:
FEMALE
40-60 years
Phase:
NA
Brief Summary
This trial has a randomized, single-blind, single-center, parallel-controlled design, with participant screening and trial implementation conducted at Guangdong Provincial People's Hospital. The study...
Detailed Description
The peri-menopausal period is a crucial transitional stage for women from middle age to old age. During this period, there is a dramatic and continuous decline in estrogen levels in women's bodies. Th...
Eligibility Criteria
Inclusion
- Women aged 40-60 years;
- Postmenopausal status or in the late menopausal transition stage. 3. Postmenopausal status is defined as: natural menopause with no menstruation in the past 12 months. The late menopausal transition stage will be defined as: amenorrhea for at least 60 days within the past 12 months;
- 4\. MRS score ≥15 points based on symptoms in the past 1 month; 5. Willing to complete the required follow-up visits during the trial period. 6. Voluntarily sign the informed consent form.
Exclusion
- History of bilateral oophorectomy or hysterectomy;
- Current or past use of magnesium L-threonate preparations or similar nutrient formulations within the last 3 months;
- Definite history of gastrointestinal diseases that may affect the absorption of the investigational drug;
- Definite history of liver diseases that may affect the metabolism of the investigational drug;
- Definite history of kidney diseases that may affect the excretion of the investigational drug, with serum creatinine levels \> 2 mg/dL (88.4 μmol/L);
- Current or recent use of hormone replacement therapy: vaginal or transdermal estrogen within the past 4 weeks; oral estrogen or progesterone within the past 8 weeks; intrauterine progesterone therapy within the past 8 weeks; progesterone implants or estrogen injection therapy within the past 3 months; estrogen pellet therapy or progesterone injection therapy within the past 6 months; or intention to use these medications during the intervention period;
- Current or past use of medications such as clonidine, methyldopa, gabapentin, pregabalin, and selective serotonin or norepinephrine reuptake inhibitors (SSRIs/SNRIs) within the past 1 month, or intention to use these medications during the intervention period;
- Current or past use of phosphodiesterase inhibitor medications within the past 1 month, or intention to use these medications during the intervention period;
- Autoimmune diseases requiring medication, current or past treatment with glucocorticoids, antirheumatic drugs, or biologics within the past 6 months, or intention to use these medications during the intervention period;
- Depression or anxiety requiring medication, current or past use of antidepressants within the past 3 months, or intention to use these medications or treatments during the intervention period;
- Current or past use of hypnotic medications such as diazepam or triazolam within the past 2 weeks, or intention to use these medications during the intervention period;
- Osteoarthritis, osteoporosis, or other musculoskeletal diseases requiring medication;
- Known allergy to magnesium L-threonate;
- History of malignancy, or life expectancy less than 1 year;
- Major surgery within the past 6 months, or intention to undergo surgery during the intervention period, including but not limited to cardiac surgery or joint replacement;
- Currently pregnant, having given birth within the past 3 months, planning pregnancy during the study period, or unwilling to use conventional barrier contraception or abstain from sexual activity to prevent pregnancy if not fully menopausal;
- Currently breastfeeding, having breastfed within the past 3 months, or planning to breastfeed during the study period;
- Unable or unwilling to provide informed consent, complete questionnaires, or attend study visits;
- Participation in other interventional studies;
- Other conditions judged by the investigator as unsuitable for trial participation. These conditions may make potential participants highly unlikely to adhere to the study protocol, including plans to relocate, substance abuse, severe psychiatric issues, or severe dementia.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06959745
Start Date
May 15 2025
End Date
December 30 2025
Last Update
May 7 2025
Active Locations (1)
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1
Global Health Research Center,Guangdong Provincial People's Hospital(Guanadong Academy of Medical Sciences)
Guangzhou, Guangdong, China