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Release: Release: Immediate

Jan. 4, 2000

UI invites people with mild thyroid failure to take part in cholesterol study

IOWA CITY, Iowa -- University of Iowa Health Care researchers invite people with mild thyroid failure to participate in a study of the safety and effectiveness of Synthroid in reducing low density lipoprotein (LDL) cholesterol.

Participants must be aged 35 to 75 and willing to make approximately 14 visits to the UI Hospitals and Clinics over the12-month study period. Prospective participants must not be receiving thyroid hormone replacement therapy or, with physician supervision, must be able to discontinue thyroid hormone replacement therapy. Women must not be pregnant or planning to conceive while enrolled in the study. Compensation is available, and all medication, tests and examinations will be provided free of charge.

People with mild thyroid failure may experience symptoms such as depression, fatigue, dry skin, brittle nails, inability to concentrate, loss of appetite, muscle cramps, weight gain, hoarseness. Women with the condition may have menstrual irregularity.

The study is a double-blinded trial for the first six months. Participants will receive either the Synthroid, or a placebo but neither the participants nor the investigators will know who is receiving which medication. During the remaining six months, all participants will receive only the Synthroid.

LDL cholesterol is known as the "bad" cholesterol component in blood, while high density lipoprotein (HDL) cholesterol is known as the "good" component. High LDL levels in blood have been associated with increased risk of heart problems.

When the thyroid level falls, LDL cholesterol can become elevated, said Udaya M. Kabadi, M.D., UI associate professor (clinical) of internal medicine and the study's lead investigator.

"In addition to studying whether Synthroid can reduce LDL cholesterol in people with mild thyroid failure, we'll also investigate whether the drug affects the distribution of LDL and HDL cholesterol and how the therapy affects patients' quality of life," said Kabadi, who is also a staff physician at the Veterans Affairs Medical Center in Iowa City.

Mild thyroid failure affects an estimated 7 to 17 percent of women and 2 to 14 percent of men in the United States. The disease is characterized by elevated blood thyroid-stimulating hormone (TSH) concentration. In normal conditions, the pituitary gland produces this hormone, which then stimulates the thyroid gland to produce thyroid hormones. However, in people with mild thyroid failure, Kabadi explained, the pituitary gland puts out excessive TSH in an effort to stimulate an underfunctioning thyroid gland.

For more information, call Sheila Wayson, nurse clinician and trial coordinator, toll-free at (877) 807-9590 or locally at (319) 356-4879 and ask about the thyroid / LDL study.

University of Iowa Health Care describes the partnership between the UI College of Medicine and the UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide.