KANSAS CITY, KAN. – The University of Kansas Medical Center is looking for volunteers to take part in the first definitive, large-scale clinical trial to investigate if a vitamin D supplement helps prevent or delay type 2 diabetes in adults who have prediabetes, who are at high risk for type 2.
Funded by the National Institutes of Health, the study is taking place at about 20 study sites across the United States.
The multiyear Vitamin D and Type 2 Diabetes (D2d) study will include about 2,500 people. Its goal is to learn if vitamin D – specifically D3 (cholecalciferol) – will prevent or delay type 2 diabetes in adults age 30 or older with prediabetes. People with prediabetes have blood glucose levels that are higher than normal but not high enough to be called diabetes.
“People in the Kansas City region have an important opportunity to be part of a national effort to determine whether simple vitamin D might help address the public health crisis of diabetes,” said David C. Robbins, M.D., director of the KU Diabetes Institute.
KU Medical Center is one of 20 academic medical centers conducting the study. Other sites include Baylor College of Medicine, Duke University Medical Center, Northwestern University and Stanford University Medical Center.
“Past observational studies have suggested that higher levels of vitamin D may be beneficial in preventing type 2 diabetes, but until this large, randomized and controlled clinical trial is complete, we won’t know if taking vitamin D supplements lowers the risk of diabetes,” said Anastassios G. Pittas, M.D., the study’s principal investigator at Tufts Medical Center, Boston.
D2d is the first study to directly examine if a daily dose of 4,000 International Units (IUs) of vitamin D – greater than a typical adult intake of 600-800 IUs a day, but within limits deemed appropriate for clinical research by the Institute of Medicine – helps keep people with prediabetes from getting type 2 diabetes. Based on observations from earlier studies, researchers speculate that vitamin D could reduce the diabetes risk by 25 percent. The study will also examine if sex, age or race affect the potential of vitamin D to reduce diabetes risk.
“An estimated 79 million Americans have prediabetes, and nearly 26 million more have diabetes,” said Griffin P. Rodgers, M.D., director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of NIH. “With D2d, we seek evidence for an affordable and accessible way to help prevent or delay type 2 diabetes.”
Researchers are recruiting volunteers to take part in D2d. Half of the participants will receive vitamin D. The other half will receive a placebo – a pill that has no drug effect. Participants will have check-ups for the study twice a year and will receive regular health care through their own health care providers.
The study will be double-blinded, so neither participants nor the study’s clinical staff will know who is receiving vitamin D and who is receiving placebo. The study will continue until enough people have developed type 2 diabetes to be able to make a scientifically valid comparison between diabetes development in the two groups, likely about four years.
D2d builds on previous NIH-funded studies of methods to delay or prevent type 2 diabetes, including the Diabetes Prevention Program, which showed that, separately, lifestyle changes to lose a modest amount of weight and the drug metformin are both effective in slowing development of type 2 diabetes in people with prediabetes. However, additional safe and effective preventive strategies are needed to stem the increasing numbers of people developing type 2 diabetes.
Along with Robbins, the lead investigator on the trial in Kansas City, Rebecca Opole, M.D., assistant professor of general and geriatric medicine, is the co-investigator. To take part in D2d, participants can contact KU Medical Center at 913-588-6052 or firstname.lastname@example.org. More information about the study is available at www.D2dstudy.org.
D2d (ClinicalTrials.gov number NCT01942694) is supported under NIH grant U01DK098245. The 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.