Vitamin D Supplementation and Prevention of Type 2 Diabetes
Pittas AG, Dawson-Hughes B, Sheehan P, Ware JH, Knowler WC, Aroda VR, Brodsky I, Ceglia L, Chadha C, Chatterjee R, Desouza C, Dolor R, Foreyt J, Fuss P, Ghazi A, Hsia DS, Johnson KC, Kashyap SR, Kim S, LeBlanc ES, Lewis MR, Liao E, Neff LM, Nelson J, O'Neil P, Park J, Peters A, Phillips LS, Pratley R, Raskin P, Rasouli N, Robbins D, Rosen C, Vickery EM, Staten M, D2d Research Group
The New England journal of medicine · 466 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- American Diabetes Association
- Gobierno
- Office of Dietary Supplements
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NCATS NIH HHS
- Gobierno
- NIDDK NIH HHS
- Subvenciones
- American Diabetes Association (1–14-D2d- 01); National Center for Advancing Translational Sciences (UL1TR001102); Office of Dietary Supplements (U01DK098245); National Institute of Diabetes and Digestive and Kidney Diseases (U01 DK098245); National Institute of Diabetes and Digestive and Kidney Diseases (U34DK091958)
Según 6 financiadores declarados.
Publicación
- Publicado
- 2019-06-07 · N Engl J Med · vol. 381 · número 6 · págs. 520–530
- Editorial
- Massachusetts Medical Society
- Citado
- 680 citas · más que el 100% de estudios similares · 53.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Diet and metabolism studies · Nutrition, Genetics, and Disease
- Palabras clave
- Type 2 diabetes, Medicine, Diabetes mellitus, Vitamin, Internal medicine, Vitamin D and neurology, Endocrinology
- MeSH
- humans, diabetes mellitus, type 2, prediabetic state, cholecalciferol, vitamins, vitamin d, disease-free survival, treatment failure, administration, oral, risk factors, double-blind method, dietary supplements, aged, middle aged, female, male, kaplan-meier estimate
35 autores
- Anastassios G. Pittas🇺🇸Tufts Medical Center
- Bess Dawson‐Hughes🇺🇸Tufts University; Jean Mayer Human Nutrition Research Center on Aging
- Patricia Sheehan🇺🇸Psychiatric Rehabilitation Association
- James H. Ware🇺🇸Harvard University
- William C. Knowler🇺🇸National Institute of Diabetes and Digestive and Kidney Diseases
- Vanita R. Aroda🇺🇸Brigham and Women's Hospital
- Irwin G. Brodsky
- Lisa Ceglia🇺🇸Tufts Medical Center
- Chhavi Chadha🇺🇸HealthPartners
- Ranee Chatterjee🇺🇸Duke Medical Center
- Cyrus V Desouza🇺🇸University of Nebraska Medical Center
- Rowena J Dolor🇺🇸Duke Medical Center
- John Paul Foreyt🇺🇸Baylor College of Medicine
- Paul Fuss🇺🇸Tufts Medical Center
- Adline Ghazi🇺🇸MedStar Good Samaritan Hospital
- Daniel S. Hsia🇺🇸Pennington Biomedical Research Center
- Karen Johnson🇺🇸University of Tennessee Health Science Center
- Sangeeta Rao Kashyap🇺🇸Cleveland Clinic
- Sun H. Kim🇺🇸Stanford Medicine
- Erin S. LeBlanc🇺🇸Kaiser Permanente Center for Health Research
- Michael R. Lewis🇺🇸University of Vermont
- Emilia Pauline Liao🇺🇸Northwell Health; Lenox Hill Hospital
- Lisa M. Neff🇵🇭Northwestern University
- Jason Nelson🇺🇸Tufts Medical Center
- Patrick Mahlen O'Neil🇺🇸Medical University of South Carolina
- Jean Park🇺🇸MedStar Health
- Anne L. Peters🇺🇸University of Southern California
- Lawrence S. Phillips🇺🇸Veterans Health Administration
- Richard E. Pratley🇺🇸Translational Research Institute for Metabolism and Diabetes
- Philip Raskin🇺🇸The University of Texas Southwestern Medical Center
- Neda Rasouli🇺🇸VA Eastern Colorado Health Care System
- David C. Robbins🇺🇸University of Kansas Medical Center
- Clifford james Rosen🇺🇸Maine Medical Center Research Institute
- Ellen M. Vickery🇺🇸Tufts Medical Center
- Myrlene A. Staten🇺🇸National Institute of Diabetes and Digestive and Kidney Diseases
Resumen
El texto original del estudio, en el idioma en que se publicó.
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. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; D2d ClinicalTrials.gov number, NCT01942694.).
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