Preventive Therapeutics Inc. of Athens, Ga., plans to cooperate with Nova Southeastern University in Fort Lauderdale, Fla., to conduct a double-blind, placebo-controlled trial of its nutritional supplement with CFS patients. The company’s product, Dr. Burgstiner’s Complete Thymic Formula and Vitamin/Mineral Complex, is described as “a blend of herbs, vitamins, minerals, glandulars, antioxidants, enzymes and whole food extracts designed to strengthen the immune system.”
Nutritional supplements are not currently regulated by the FDA and clinical trials are not required, although manufacturers of such products are beginning to see such studies as important to support the health claims they make, and they are anticipating possible FDA regulation.
Cheryl Feingold, PhD, Director of Clincal Research at Nova Southeastern University, said preparations are being made for the trial using FDA guidelines. Persons in the Fort Lauderdale area who are diagnosed with CFS and who would like to participate in the trial may contact her office at 954/262-1235. Names of potential subjects will be kept on file to be contacted when the trial is ready to begin.