Over a period of up to four years, diabetes specialists at UT Southwestern and at 19 other sites nationwide will track 2,500 trial participants age 30 or older who have prediabetes for the Vitamin D and Type 2 Diabetes study. People with prediabetes have blood glucose levels that are higher than normal, but not high enough to be considered diabetic.
“There is some evidence that treatment with vitamin D can prevent development of type 2 diabetes,” said Dr. Philip Raskin, Professor of Internal Medicine, who will lead the UT Southwestern investigation. “If you could prevent development of diabetes, that would save people a lot of anguish and diabetes medication cost.”
People interested in taking part in the trial at UT Southwestern can call 214-DIABETES (214-342-2383) to see if they qualify for this or other diabetes-related trials. A free blood test will determine if someone qualifies.
The American Diabetes Association estimates 79 million Americans have prediabetes – more than three times the number of people with full-blown diabetes. Nearly 26 million people, about 8.3 percent of the U.S. population, have diabetes.
The Vitamin D and Type 2 Diabetes (D2d) study is the first to examine if a daily dose of 4,000 International Units (IUs) of vitamin D in the form of D3 (cholecalciferol) prevents development of type 2 diabetes. Although the recommended daily dose of vitamin D for a healthy adult is 600 to 800 IUs, the higher dosage to be used in this trial is within limits considered safe.
“The side effects of vitamin D3 in the doses we’re going to use are few. It’s a fairly safe and inexpensive treatment,” Dr. Raskin said. Taking vitamin D supplements carries a very small risk of developing kidney stones or high levels of calcium in the blood or urine, according to the study researchers.
Based on observations from other studies, researchers suspect that vitamin D may reduce diabetes risk by 25 percent. The study also will examine whether sex, age, or race factor into the effects of vitamin D in reducing diabetes risk. The D2d study will be double-blinded, so neither participants nor the study’s clinical staff will know who is receiving vitamin D or a placebo. All study participants will receive twice-yearly check-ups.
D2d is the latest in a series of large-scale, multicenter diabetes clinical trials that UT Southwestern has taken part in to help improve diabetes care and identify the best treatments. UT Southwestern also is participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study, which will compare the benefits and side effects of four different type 2 diabetes therapies, along with earlier NIH-funded trials that included the Diabetes Control and Complications Trial, Epidemiology of Diabetes Interventions and Complications study, and Type 1 Diabetes TrialNet.
Clinical trials are important to develop new treatments to prevent, diagnose, or treat a disease. Find clinical trials at UT Southwestern or learn more about participating in clinical trials at UT Southwestern.
Dr. Raskin is a member of UT Southwestern’s division of endocrinology, which was recognized by U.S. News & World Report in its 2012-2013 “Best Hospitals” annual issue. He also has an appointment in the Touchstone Center for Diabetes Research, which focuses on basic science and clinical aspects of diabetes. Others on the clinical trial’s local research team include Dr. Chanhaeng Rhee, Assistant Professor of Internal Medicine, and Dr. Naim Maalouf, Associate Professor of Internal Medicine.
D2d (ClinicalTrials.gov number NCT01942694) is supported under NIH grant U01DK098245. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the primary sponsor of the trial, with additional support from the NIH Office of Dietary Supplements and the American Diabetes Association. Support in the form of educational materials is provided by the National Diabetes Education Program.
About UT Southwestern Medical Center
UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty includes many distinguished members, including five who have been awarded Nobel Prizes since 1985. Numbering more than 2,700, the faculty is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 90,000 hospitalized patients and oversee more than 1.9 million outpatient visits a year.
Media Contact: Debbie Bolles