TY - JOUR
T1 - Vitamin D supplementation and prevention of type 2 diabetes
AU - Pittas, Anastassios G.
AU - Dawson-Hughes, Bess
AU - Sheehan, Patricia
AU - Ware, James H.
AU - Knowler, William C.
AU - Aroda, Vanita R.
AU - Brodsky, Irwin
AU - Ceglia, Lisa
AU - Chadha, Chhavi
AU - Chatterjee, Ranee
AU - Desouza, Cyrus
AU - Dolor, Rowena
AU - Foreyt, John
AU - Fuss, Paul
AU - Ghazi, Adline
AU - Hsia, Daniel S.
AU - Johnson, Karen C.
AU - Kashyap, Sangeeta R.
AU - Kim, Sun
AU - LeBlanc, Erin S.
AU - Lewis, Michael R.
AU - Liao, Emilia
AU - Neff, Lisa M.
AU - Nelson, Jason
AU - O'Neil, Patrick
AU - Park, Jean
AU - Peters, Anne
AU - Phillips, Lawrence S.
AU - Pratley, Richard
AU - Raskin, Philip
AU - Rasouli, Neda
AU - Robbins, David
AU - Rosen, Clifford
AU - Vickery, Ellen M.
AU - Staten, Myrlene
N1 - Funding Information:
Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; D2d ClinicalTrials.gov number, NCT01942694.
Funding Information:
Dr. Dawson-Hughes reports receiving grant support, paid to Tufts University, from Pfizer and DSM and travel support from Abiogen Pharma; Dr. Aroda, receiving consulting fees, paid to her institution, from Adocia, grant support, paid to her institution, and consulting fees from AstraZeneca/Bristol-Myers Squibb, Novo Nordisk, and Sanofi, consulting fees from BD and Zafgen, and grant support, paid to her institution, from Calibra Medical, Eisai, Janssen, and Theracos; Dr. Ceglia, receiving grant support from DSM; Dr. Desouza, receiving advisory board fees from Novo Nordisk; Dr. Kim, receiving consulting fees from Sanofi; Dr. LeBlanc, receiving grant support, paid to her institution, from Merck; Dr. Neff, receiving grant support from GI Dynamics; Dr. O’Neil, receiving grant support from Weight Watchers International, advisory board fees from Janssen, advisory board fees and fees for presentations from Vindico Medical Education, fees for CME programs from WebMD, lecture fees from Robard, and grant support and lecture fees from Novo Nordisk; Dr. Phillips, receiving grant support and advisory board fees from Janssen Pharmaceuticals, receiving advisory board fees from Profil Institute for Clinical Research, receiving grant support from Merck, Amylin Pharmaceuticals, Eli Lilly, Novo Nordisk, Sanofi, PhaseBio, Roche, AbbVie, Vascular Pharmaceuticals, GlaxoSmithKline, Pfizer, and Kowa Research Institute, and serving as cofounder, officer, and board member of and holding stock in Diasyst; and Dr. Pratley, receiving lecture fees, paid to his institution, and consulting fees, paid to his institution, from AstraZeneca, consulting fees, paid to his institution, from Boehringer Ingelheim, Eisai, GlaxoSmithKline, Gly-tec, Janssen, Mundipharma, and Pfizer, grant support, paid to his institution, from Lexicon Pharmaceuticals, grant support, paid to his institution, and consulting fees, paid to his institution, from Ligand Pharmaceuticals, Eli Lilly, Merck, and Sanofi, grant support, paid to his institution, and lecture fees, paid to his institution, from Novo Nordisk and Takeda, and consulting fees from Sanofi US Services. No other potential conflict of interest relevant to this article was reported.
Funding Information:
The planning phase of the D2d trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through a multicenter clinical study implementation planning grant to Tufts Medical Center in Boston (U34DK091958; principal investigator, Dr. Pittas). Planning was also supported, in part, by the Intramural Research Program of the NIDDK. The conduct of the trial was supported primarily by the NIDDK and the Office of Dietary Supplements of the National Institutes of Health through the multicenter clinical study cooperative agreement (U01DK098245; principal investigator, Dr. Pittas) to Tufts Medical Center, where the D2d Coordinating Center is based. The U01 grant mechanism establishes the NIDDK project scientist (Dr. Staten) as a member of the D2d Research Group. The trial also received secondary funding from the American Diabetes Association to Tufts Medical Center (1-14-D2d-01; principal investigator, Dr. Pittas). Educational materials were provided by the National Diabetes Education Program.
Publisher Copyright:
Copyright © 2019 Massachusetts Medical Society.
PY - 2019/8/8
Y1 - 2019/8/8
N2 - BACKGROUND Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown. METHODS We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100 to 125 mg per deciliter; plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter; and glycated hemoglobin level, 5.7 to 6.4%) and no diagnostic criteria for diabetes to receive 4000 IU per day of vitamin D3 or placebo, regardless of the baseline serum 25-hydroxyvitamin D level. The primary outcome in this time-to-event analysis was new-onset diabetes, and the trial design was event-driven, with a target number of diabetes events of 508. RESULTS A total of 2423 participants underwent randomization (1211 to the vitamin D group and 1212 to the placebo group). By month 24, the mean serum 25-hydroxyvitamin D level in the vitamin D group was 54.3 ng per milliliter (from 27.7 ng per milliliter at baseline), as compared with 28.8 ng per milliliter in the placebo group (from 28.2 ng per milliliter at baseline). After a median follow-up of 2.5 years, the primary outcome of diabetes occurred in 293 participants in the vitamin D group and 323 in the placebo group (9.39 and 10.66 events per 100 person-years, respectively). The hazard ratio for vitamin D as compared with placebo was 0.88 (95% confidence interval, 0.75 to 1.04; P = 0.12). The incidence of adverse events did not differ significantly between the two groups. CONCLUSIONS Among persons at high risk for type 2 diabetes not selected for vitamin D insufficiency, vitamin D3 supplementation at a dose of 4000 IU per day did not result in a significantly lower risk of diabetes than placebo.
AB - BACKGROUND Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown. METHODS We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100 to 125 mg per deciliter; plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter; and glycated hemoglobin level, 5.7 to 6.4%) and no diagnostic criteria for diabetes to receive 4000 IU per day of vitamin D3 or placebo, regardless of the baseline serum 25-hydroxyvitamin D level. The primary outcome in this time-to-event analysis was new-onset diabetes, and the trial design was event-driven, with a target number of diabetes events of 508. RESULTS A total of 2423 participants underwent randomization (1211 to the vitamin D group and 1212 to the placebo group). By month 24, the mean serum 25-hydroxyvitamin D level in the vitamin D group was 54.3 ng per milliliter (from 27.7 ng per milliliter at baseline), as compared with 28.8 ng per milliliter in the placebo group (from 28.2 ng per milliliter at baseline). After a median follow-up of 2.5 years, the primary outcome of diabetes occurred in 293 participants in the vitamin D group and 323 in the placebo group (9.39 and 10.66 events per 100 person-years, respectively). The hazard ratio for vitamin D as compared with placebo was 0.88 (95% confidence interval, 0.75 to 1.04; P = 0.12). The incidence of adverse events did not differ significantly between the two groups. CONCLUSIONS Among persons at high risk for type 2 diabetes not selected for vitamin D insufficiency, vitamin D3 supplementation at a dose of 4000 IU per day did not result in a significantly lower risk of diabetes than placebo.
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U2 - 10.1056/NEJMoa1900906
DO - 10.1056/NEJMoa1900906
M3 - Article
C2 - 31173679
AN - SCOPUS:85068644253
VL - 381
SP - 520
EP - 530
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 6
ER -