About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Magnesium-L-Threonate
DrugMagnesium L-threonate, 1740 mg, taken orally, twice a day, for 8 weeks.
Placebo
DrugPlacebo, 1740 mg, taken orally, twice a day, for 8 weeks.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Change of Menopause Quality of Life (MENQOL) Questionnaire
The Menopause Quality of Life Questionnaire (MENQOL) assesses the impact of menopausal symptoms across four domains: vasomotor, sexual, physical, and psychosocial (Maturitas 24:161-175, 1996). Symptoms like hot flashes, vaginal dryness, and depression are evaluated. Participants first indicate if they've had symptoms in the past month, then rate bothersomeness on a 7-point scale. Ratings are recorded from 2 (symptom present but not bothersome) to 8 (extremely bothered). Domain scores are calculated as the mean of item scores; higher scores mean more troublesome symptoms and poorer quality of life. The score of MENQOL Questionnaire is from 8 to 232.
Change of EuroQoL 5-dimension 5-Level (EQ5D-5L)
The EQ-5D 5-Level (EuroQol Five Dimensions) is a standardized questionnaire designed to measure health status and health-related quality of life (Qual Life Res 2011;20:1727-36). It evaluates five dimensions: mobility, self-care, usual activities (e.g., work, housework), pain/discomfort, and anxiety/depression. Scoring Ranges EQ-VAS (Visual Analog Scale): Range: 0-100. Interpretation: 0 represents the worst imaginable health state, and 100 represents the best possible health state. This scale reflects the respondent's self-assessment of overall health. EQ-5D Index Score (Utility Value): Range: 0 to 1. Interpretation: 1: Perfect health. 0: Equivalent to death. Negative values: Worse than death (e.g., severe chronic conditions).
Change of Brief Pain Inventory-Short Form (BPI-SF)
The Brief Pain Inventory-Short Form (BPI-SF) is a widely used tool for assessing pain (Pain. 1983;17(2): 197-210). This 14-item questionnaire requires respondents to rate their joint pain experienced over the past week and the extent to which the pain disrupts their activities. Ratings are given on a scale of 0 to 10, where 0 indicates "no pain" and 10 represents "pain as severe as imaginable". The range of the score number is from 0 to 140 points.
Change of Hot flash Score
The Hot Flash Score was measured using a prospective, self-report hot flash diary, which women were instructed to fill out in real-time (J Clin Oncol 19:4280-4290, 2001). The determination of hot flash scores involved allocating points to each hot flash according to the reported severity. Specifically, a hot flash was assigned 1 point for mild severity, 2 points for moderate severity, 3 points for severe severity, and 4 points for very severe severity. For each patient, the points assigned to hot flashes on each day were summed up, and then these daily totals were averaged over each week of the trial period. The minimum of the score is 0, and there is no maximum limit.
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