PXE Magnesium Clinical Trial FAQ
Frequently Asked Questions
Clinical Trial of Magnesium Supplements for Treatment of Pseudoxanthoma Elasticum
Below find answers to frequently asked questions about the PXE magnesium supplement clinical trial. Click to expand or hide.
To be in this trial, participants must have a biopsy-confirmed diagnosis of PXE, be at least 18 years old, and have visible skin lesions. It is also important that participants not have any major medical problems with their kidney function in order to protect their safety during the trial. Additional criteria can be found on clinicaltrials.gov. Participants can leave the trial at any point. [April 2013]
At the end of the two-year period, researchers measure whether each participant’s calcium deposits in the skin increased or decreased. Researchers predict that during the first year, participants in the treatment group will show a decrease in calcium deposits in the skin. For the second year evaluation, they predict that all participants will show a decrease in calcium deposits. [April 2013]
For a photo essay of Elizabeth Terry's experience of the PXE clinical trial, please read Making History of PXE.
Random assignment helps protect participants and researchers from exhibiting either intentional or unintentional bias towards the treatment. For example, it is clear to the participants in this clinical trial that the researchers hope magnesium supplementation will decrease the appearance of skin lesions. If participants know they are taking the magnesium supplement, they may unintentionally introduce their own bias and think they see a decrease in skin lesions when it is not really true. The same applies to researchers – if they know a certain participant is taking the magnesium supplement, they may falsely believe they see a decrease in skin lesions because of their pre-existing belief that magnesium will decrease calcium deposits. It is very important for the integrity of the clinical trial that neither the participants nor the researchers choose to which group participants are assigned. [April 2013]
Treatment may not be effective
The purpose of clinical trials is to scientifically test whether treatments are effective. Before the clinical trial begins, researchers may believe the treatment will be effective, but the trial may prove otherwise. The treatment may be ineffective, may result in serious adverse reactions, and/or may only be effective on a subset of the population with certain characteristics. Participants should not assume that the treatment will work.
Help others by contributing to medical research
In clinical trials both the treatment and control groups are equally important. The treatment group allows researchers to observe and record changes as a result of the treatment. The control group helps researchers isolate the treatment’s effects on the experiment and rule out alternate explanations of the experiment’s results. All participants in clinical trials are actively advancing medical research for the benefit of others. [April 2013]
Last updated May 18th, 2016