Can Vitamin D Prevent or Delay Type 2 Diabetes in Adults with Prediabetes: Large Study Underway
Based on earlier studies, researchers speculate that vitamin D could reduce the diabetes risk by 25 percent; enrollment open in trials
Oct. 21, 2013 - Researchers have begun the first definitive, large-scale clinical trial to investigate if a vitamin D supplement helps prevent or delay type 2 diabetes in older adults who have prediabetes, who are at high risk for developing 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 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.
“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.”
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“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 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 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.
Low Vitamin D Levels a Risk Factor for Pneumonia in Older People
April 30, 2013 - A University of Eastern Finland study showed that low serum vitamin D levels are a risk factor for pneumonia. The risk of contracting pneumonia was more than 2.5 times greater in subjects with the lowest vitamin D levels than in subjects with high vitamin D levels. The results were published in Journal of Epidemiology and Community Health.
The follow-up study carried out by the UEF Institute of Public Health investigated the link between serum vitamin D3 and the risk of contracting pneumonia. The study involved 1,421 subjects living in the Kuopio region in Eastern Finland.
The results showed that during the follow-up, subjects with vitamin D3 levels representing the lowest third were more than 2.5 times more likely to contract pneumonia than subjects with high vitamin D3 levels.
The risk of contracting pneumonia also grew by age, and was greater in men than women. At baseline, the mean serum D3 concentration of the study population was 43.5 nmol/l, and the mean age of the study population was 62.5 years.
Earlier research has shown that vitamin D deficiency weakens the immune system and increases the risk of mild respiratory infections. This University of Eastern Finland study was the first one to establish that vitamin D deficiency also increases the risk of contracting pneumonia in the ageing general population.
The recommended daily intake of vitamin D in Finland is 20 micrograms for those over 60 years of age.
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 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.
Learn more about the study, including how to take part in D2d, at http://www.D2dstudy.org.
The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine 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 information about the NIDDK and its programs, see http://www.niddk.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's 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.