- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
NIH Study to Examine Whether Vitamin D Prevents Diabetes
Researchers test much-touted vitamin in subjects with prediabetes (October 21)
Researchers have begun the first definitive, large-scale clinical trial to investigate whether a vitamin D supplement helps prevent or delay type 2 diabetes in adults who have prediabetes, who are at high risk for developing type 2. Funded by the National Institutes of Health (NIH), the study is being conducted at about 20 sites in the U.S.
The double-blind, placebo-controlled Vitamin D and Type 2 Diabetes (D2d) trial will include about 2,500 subjects. Its goal is to learn whether vitamin D — specifically D3 (cholecalciferol) — will prevent or delay type 2 diabetes in adults aged 30 years or older with prediabetes. People with prediabetes have blood glucose levels that are higher than normal but not high enough to be called diabetes.
“Vitamin D use has risen sharply in the U.S. in the last 15 years, since it has been suggested as a remedy for a variety of conditions, including prevention of type 2 diabetes. But we need rigorous testing to determine if vitamin D will help prevent diabetes. That’s what D2d will do,” said Myrlene Staten, MD, D2d project officer at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the NIH.
D2d will be the first study to examine directly whether a daily dose of 4,000 International Units (IUs) of vitamin D — greater than a typical adult intake of 600 to 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%. The new study will also examine whether sex, age, or race affects the potential of vitamin D to reduce diabetes risk.
Source: NIH; October 21, 2013.