An interventional study of 400mg Magnesium Glycinate BID and Placebo in Hot Flashes, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
The goal of this study is to further evaluate the effect of magnesium on the symptoms of menopause, specifically vasomotor symptoms (VMS) in breast cancer patients and/or women at an elevated risk of breast cancer.
Hot flashes are one of the most common symptoms that are experienced in women during perimenopause, menopause, and as a result of treatment of cancer such as breast cancer. Hot flashes, also known as vasomotor symptoms (VMS) may decrease a woman's quality of life due to discomfort, disruption of daily life, interruption of sleep, and worsening of depression. Previously, estrogen-based therapy was the primary treatment choice for VMS. However, in recent years, this has been considered less favorable due to the increased risk of breast cancer associated with estrogen-based therapy.
While medications such as certain antidepressants, gabapentin and clonidine are available as non-hormonal treatment options, they appear to be less effective in comparison to estrogen therapy with reported adverse effects.
Magnesium supplementation has been found to have very promising results in alleviating VMS in patients with a history of breast cancer. The goal of this study is to further investigate the effects of administering magnesium supplementation in reducing the effects of hot flashes in this targeted population. Our aim is to create a controlled trial using different dosages of magnesium glycinate in the management of hot flashes. Participants will be asked to complete surveys for data collection and analysis.
285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.
This study's enrollment of 40 is below the median of 90 across 255 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prescription for an 8 week supply (+/- 4 days) of Magnesium Glycinate will be sent to the pharmacy for patient pick up. Study Coordinator will then dispense study diaries (Supplementation Diary and Hot Flash Diary) with instructions on how to complete for the eight week study duration. Study Coordinator will discuss upcoming phone calls on Weeks 2-8 to complete the MDASI by phone and the best times to do so with the patient. Coordinator will schedule a return visit with the Patient approximately 9 weeks after the start of the study for follow-up. At follow-up, Coordinator will retrieve Patient Diaries (Hot Flash Diary and Medication Diary), perform supplement reconciliation, and exit Patient from the study.
Dietary Supplement: 400mg Magnesium Glycinate BID
Prescription for an 8 week supply (+/- 4 days) of placebo will be sent to the pharmacy for patient pick up. Study Coordinator will then dispense study diaries (Supplementation Diary and Hot Flash Diary) with instructions on how to complete for the eight week study duration. Study Coordinator will discuss upcoming phone calls on Weeks 2-8 to complete the MDASI by phone and the best times to do so with the patient. Coordinator will schedule a return visit with the Patient approximately 9 weeks after the start of the study for follow-up. At follow-up, Coordinator will retrieve Patient Diaries (Hot Flash Diary and Medication Diary), perform supplement reconciliation, and exit Patient from the study.
Other: Placebo
400mg Magnesium Glycinate BID for 8 weeks.
Placebo BID for 8 weeks.
Percent change in hot flash frequency
The primary endpoint of this study will be the percent change in hot flash frequency from baseline to week 8. A two independent sample z-test (assuming equal variances) or a Wilcoxon rank-sum test will be used for the analysis of this endpoint.
Time frame: 8 weeks.
Average change in hot flash frequency from baseline to week 8
The secondary analysis, we will also look at the average change in hot flash frequency from baseline to week 8 and compare these means using a two-sample t-test or a Wilcoxon rank-sum test. Adverse events (as captured using the NCI CTCAE version 4) will be compared between the two investigational arms using summary statistics. Frequencies of adverse events will be compared using chi-square tests or Fisher's exact tests. Change in QOL (as measured by the MDASI) from baseline to week 8 will be compared for each question between the investigational arms using two sample t-tests or Wilcoxon rank sum tests.
Time frame: 8 weeks
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Plan to share: No
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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