Study Reports Preliminary Results of CBD Liver Safety
A patient-centered clinical trials company called ValidCare has recently concluded a 7-month study of the effects of CBD use on the liver. Overall, their findings have been advantageous to the consumer as their “investigators report to FDA no evidence of liver toxicity in the 839 adults consuming oral CBD”. This study was in response to the FDA’s request for science-based data to help determine the appropriate regulations for hemp derived CBD products.
The 7 Month Testing Process
With the help of twelve CBD product companies and 839 participants, ValidCare carried out a 7-month study of the effects of CBD on the liver. The study began in August 2020 and came to a close in February 2021. It may seem like conducting a study during the pandemic would prove to be problematic, but the “use of ValidCare’s decentralized clinical research platform and partnership with national laboratories enabled participants and principal investigators to successfully complete this first cohort” and the FDA and brands involved were delivered results within six weeks.
The main purpose of this 7-month study was to “observe any potential liver effects in adults ingesting oral forms of hemp derived CBD for a minimum of 60 days”. To successfully complete this study, ValidCare needed a minimum of 681 participants, and with the help of the participating product companies, they were able to have over 830 participants complete the study.
Over the course of the 7-months ValidCare has found “no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions”. Three participants were reported to have three times the normal levels of the liver enzyme ALT, but they were all taking prescription medications that are known to elevate liver enzymes.
The results of the study have been encouraging as it provides sufficient science-based data to the FDA, for them to take action on safety regulations for CBD in the future. That being said, this 7-month study has only been the first cohort, and ValidCare will continue to analyze real-world data and perform a second cohort to add to the statistical certainty for liver safety. ValidCare is “excited for [their] principal investigators to continue, expand and report out on this foundational work in the next few months. Once completed, safety results of this study will be shared with participation brands and the FDA.”
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