Magnesium-L-Threonate Improves Menopausal Symptoms

NCT06959745 | Not Yet Recruiting

• 1 other identifier: KY2025-240-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 evaluate the efficacy of oral magnesium L-threonate supplementation on improving menopausal symptoms and quality of life among peri/post-menopausal women. This trial aims to explore whether oral magnesium L-threonate supplementation could alleviate menopausal syndromes. Participants will randomly assigned to conduct oral magnesium L-threonate supplementation or placebo for 8 weeks. Face-to-face and internet follow up will be conducted once per 2 weeks.

Conditions

Menopause Syndrome; Magnesium

Keywords

menopause syndrome

Outcome Measures

Primary Outcomes (1)

• Change of Menopausal Rating Scale (MRS)

  The Menopausal Rating Scale (MRS) is a widely used tool for assessing the severity of menopausal symptoms and their impact on a woman's quality of life (Health Qual Life Outcomes 2004;2:67). The MRS consists of multiple domains and specific items. Typically, it includes categories such as somatic symptoms (like hot flashes, sweating, sleep disturbances), psychological symptoms (including mood swings, anxiety, and depression), and urogenital symptoms (such as vaginal dryness and urinary problems). Each item within these domains is scored on a numerical scale, usually ranging from 0 to 3 or 0 to 4, depending on the severity of the symptom, and the maximum total score would be 44. A score of 0 often indicates the absence of the symptom, while higher scores reflect increasing levels of discomfort or impairment.

  From randomization to the end of treatment at 8 weeks

Secondary Outcomes (11)

• Change of Menopause Quality of Life (MENQOL) Questionnaire

  From randomization to the end of treatment at 8 weeks

• Change of EuroQoL 5-dimension 5-Level (EQ5D-5L)

  From randomization to the end of treatment at 8 weeks

• Change of Brief Pain Inventory-Short Form (BPI-SF)

  From randomization to the end of treatment at 8 weeks

• Change of Hot flash Score

  From randomization to the end of treatment at 8 weeks

• Change of Insomnia Severity Index（ISI）

  From randomization to the end of treatment at 8 weeks

Study Arms (2)

Magnesium-L-Threonate

EXPERIMENTAL

Drug: Magnesium-L-Threonate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Magnesium-L-Threonate DRUG

Magnesium L-threonate, 1740 mg, taken orally, twice a day, for 8 weeks.

Magnesium-L-Threonate

Placebo DRUG

Placebo, 1740 mg, taken orally, twice a day, for 8 weeks.

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• \. 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Global Health Research Center,Guangdong Provincial People's Hospital(Guanadong Academy of Medical Sciences)

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

threonic acid

Central Study Contacts

Sicong Ma

CONTACT

+8615714853245; masc21@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy director of global health research center

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 7, 2025
• Study Start: May 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

CN (1)