Date Published: 21 October 2013

Large study to find out if vitamin D prevents diabetes

Researchers in the United States (USA) have begun a large-scale clinical trial to investigate if taking vitamin D supplements helps to prevent or delay type 2 diabetes in adults who have prediabetes - and who are therefore considered to be at high risk of developing type 2 diabetes. The study is taking place at about 20 locations across the United States. ... See also what is diabetes?, diabetes in the news and vitamin D in the news.

The multiyear Vitamin D and Type 2 Diabetes (D2d) study will involve about 2,500 people. The purpose of this study is to find out if vitamin D - specifically D3 (cholecalciferol) - will prevent or delay type 2 diabetes in adults aged 30 or older who have already been diagnosed with 'prediabetes'. That is, people with prediabetes have blood glucose levels that are higher than normal but not high enough for the person to be diagnosed as a diabetic.

"This study aims to definitively answer the question: Can vitamin D reduce the risk of developing type 2 diabetes?" said Myrlene Staten, M.D., D2d project officer at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of NIH.
" 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."

"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.

According to the United States' National Institutes of Health (NIH), which is funding this study, D2d will be the first study to directly examine if a daily dose of 4,000 International Units (IUs) of vitamin D, which is 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 to prevent people with prediabetes from developing type 2 diabetes. Based on observations from earlier studies, researchers speculate that vitamin D could reduce the risk of diabetes by 25% percent. The study will also examine if gender, 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 NIDDK Director Griffin P. Rodgers, M.D.
" With D2d, we seek evidence for an affordable and accessible way to help prevent or delay type 2 diabetes."

Researchers are still recruiting volunteers to take part in D2d. Half of the participants will receive vitamin D. The other half will receive a placebo which is a pill that contains no vitamins or drugs related to the subject matter being investigated in the trial. Participants will have check-ups for the study twice a year, and will receive regular health care through their own usual health care providers. The study will be "double-blinded", which means that neither the participants (the volunteers who are the subjects of the trial) 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. This is expected to take approximately four years.

More about this study:

D2d builds on previous NIH-funded studies of methods to delay or prevent type 2 diabetes, including the Diabetes Prevention Program, which demonstrated 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.

The NIDDK, part of the NIH, conducts and supports research on diabetes and other endocrine (endocrine diseases) and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more about the NIDDK and its programs, see http://www.niddk.nih.gov.

About NIH:
The National Institutes of Health (NIH), the United States' medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov - statement understood to be correct as of publication date.

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