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:
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
SN - 0028-4793
VL - 381
SP - 520
EP - 530
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 6
ER -