Baylor College of Medicine is recruiting volunteers to take part in the first definitive, large-scale clinical trial funded by the National Institutes of Health to investigate if a vitamin D supplement helps prevent or delay type 2 diabetes in adults who have prediabetes, meaning they are at high risk for developing the disease.
The multiyear Vitamin D and Type 2 Diabetes (D2d) study is taking place at about 20 study sites across the United States and 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 aged 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.
First study of its kind
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.
“This study is important because it aims to definitively answer the question whether or not vitamin D will reduce the risk of developing type 2 diabetes. We hope that our study will show that this very affordable and accessible strategy will help prevent or delay its onset,” says Dr. John Foreyt, professor of medicine and principal investigator of the BCM site.
Half of the participants in the study 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.
Four years of results
The study will be double-blind, 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 preventative strategies are needed to stem the increasing numbers of people developing type 2 diabetes.
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.
For more information or to volunteer for the study, call 713-798-3741 or email VitDstudy@bcm.edu.