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Elk Velvet Antler Study Announced

Elk Velvet Antler Study Announced, Canadian Elk & Deer Farmer, Late Summer,2000, Pg.50

(Reprinted with permission from the Canadian Elk & Deer Farmer magazine)

A research award of over one-quarter of a million dollars has been granted to study the effects of Elk Velvet Antler (EVA) on rheumatoid arthritis (RA) suffers. The Canadian Health Services Research Foundation approved the grant for a three-year study to a University of Alberta research team.

A pilot study to determine the safety of EVA and to determine a dose range has already been completed. Forth participants each took 6 capsules containing EVA. This study provided enough evidence to indicate that a larger study was needed. Elk Velvet Antler was determined to be safe and did not interfere with the patientsí existing therapy and there were measurable effects on the participants receiving the largest dosages of EVA.

The new study will take up to three years to complete. It will be a triple-blind, placebo-controlled, randomized clinical trial in which two different treatment groups (EVA and placebo) will participate. It is estimated that it will take up to two years just to recruit the 220 patients required for the trial. This expectation is based on expressed public interest in the pilot study and the number of RA patients who have already indicated a willingness to be involved. Studies indicate that RA patients are highly motivated to find effective therapies for their chronic condition and the recruitment time may be less than the 24 months anticipated.

Subjects will be recruited from the rheumatology practices of Dr. Anthony Russell of the University of Alberta and partners (Drs. Davis, Aaron, and Maksomowych) and if necessary, other local rheumatologists. Specific criteria must be met for participants to be included in the study. Some symptoms, including a measurable level of pain, must be present. The patientís prescribed medication dosage must be stable for at least four weeks prior to the start of the study; The participants must also be able to commit at least 6 months to the study.

A project director and a research assistant will be hired to conduct the study. Under the direction of Dr. Russell, they will monitor the patients and conduct pain assessment studies, measure joint tenderness and swelling (on a specific sale), conduct blood tests to measure inflammation and record physiciansí assessments of the individual patients. An extremely important part of the study will be the patientsí own assessments of their pain, functionality and quality of life. In most studies of this type, 10 to 30% of participants will respond to the placebo and self-assessment is critical to determining the placebo effect, as well as actual product effect.

A random code will be set up to determine which participants receive the placebo or the Elk Velvet Antler capsules. 110 participants will receive EVA and the other 110 will make up the control group and receive a placebo. Neither the investigators, research nurse, research assistant, patients, lab technicians, nor data analysts will be aware of the treatment provided to the patient. An individual not otherwise connected to the study will be responsible for assigning patients to treatment groups, packaging the capsules and preparation of the code envelopes and group assignments. The code will not be broken until the study is complete.

Each patient will take 4 capsules a day; each EVA capsule will contain 250 mg of whole beam EVA. Throughout the study, patients will continue to follow their current Rheumatoid Arthritis treatment regimen, and they will be requested not to use new medications, including over the counter preparations, to control their RA symptoms. At each clinic visit and telephone call a complete listing of all medications (prescribed and over-the-counter) will be noted.

Patients will be seen at the onset of the study, and at three and six month intervals. Monthly telephone calls will keep the researchers in contact with the participants and help ensure motivation. Case report forms will be completed at each contact and the data recorded.