Clinical Trials Directory

Trials / Completed

CompletedNCT03564665

Investigating Magnesium Glycinate in Structure/Function Role of Hot Flashes.

A Randomized, Placebo Controlled, Single Blinded Trial of 400mg of Magnesium Glycinate BID Investigating the Body's Structure/Function Role of Hot Flashes.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
Female
Age
25 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENT400mg Magnesium Glycinate BID400mg Magnesium Glycinate BID for 8 weeks.
OTHERPlaceboPlacebo BID for 8 weeks.

Timeline

Start date
2018-07-24
Primary completion
2021-04-10
Completion
2021-04-10
First posted
2018-06-21
Last updated
2021-04-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03564665. Inclusion in this directory is not an endorsement.