Vitamin D supplementation and prevention of type 2 diabetes
Open accessAbstract
BACKGROUNDObservational 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. METHODSWe 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 D 3 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. RESULTSA 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. CONCLUSIONSAmong persons at high risk for type 2 diabetes not selected for vitamin D insufficiency, vitamin D 3 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.govnumber, NCT01942694.
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The D2d prospective RCT showed no significant benefit of vitamin D versus placebo on the progression to type 2 diabetes in individuals at high risk.
“Although the Vitamin D and Type 2 Diabetes Study (D2d) prospective RCT showed no significant benefit of vitamin D versus placebo on the progression to type 2 diabetes in individuals at high risk (223), post hoc analyses and metaanalyses suggest a potential benefit in specific populations (223)(224)(225)(226).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [223]
Post hoc analyses and meta-analyses suggest a potential benefit of vitamin D supplementation in specific populations.
“Although the Vitamin D and Type 2 Diabetes Study (D2d) prospective RCT showed no significant benefit of vitamin D versus placebo on the progression to type 2 diabetes in individuals at high risk (223), post hoc analyses and metaanalyses suggest a potential benefit in specific populations (223)(224)(225)(226).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [223]
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- Authors
- Pittas, A. G., Dawson-Hughes, B., Sheehan, P., Ware, J. H., Knowler, W. C., Aroda, V. R., Brodsky, I., Ceglia, L., Chadha, C., Chatterjee, R., Desouza, C., Dolor, R., Foreyt, J., Fuss, P., Ghazi, A., Hsia, D. S., Johnson, K. C., Kashyap, S. R., Kim, S., LeBlanc, E. S., Lewis, M. R., Liao, E., Neff, L. M., Nelson, J., O’Neil, P., Park, J., Peters, A., Phillips, L. S., Pratley, R., Raskin, P., Rasouli, N., Robbins, D., Rosen, C., Vickery, E. M., & Staten, M.
- Affiliations
- Tufts University (US)
- From Tufts Medical Center (A.G.P., L.C., P.F., J.N., E.M.V.), the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (B.D.-H.), Brigham and Women’s Hospital (V.R.A.), and Harvard School of Public Health (J.H.W.), Boston, and the Spaulding Rehabilitation Network, Charlestown (P.S.) — all in Massachusetts; National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ (W.C.K.); the Maine Medical Center (I.B.) and the Maine Medical Center Research Institute (C.R...
- Pennington Biomedical Research Center (US)
- University of Vermont (US)
- Northwestern University (US)
- University of Southern California (US)
- ORCID
- Pittas, Anastassios G.
- Sheehan, Patricia
- Knowler, William C.
- Aroda, Vanita R.
- Brodsky, Irwin
- Ceglia, Lisa
- Chatterjee, Ranee
- Desouza, Cyrus
- Dolor, Rowena
- Fuss, Paul
- Ghazi, Adline
- Hsia, Daniel S.
- Johnson, Karen C.
- Kashyap, Sangeeta R.
- Kim, Sun
- LeBlanc, Erin S.
- Lewis, Michael R.
- Neff, Lisa M.
- Nelson, Jason
- Peters, Anne
- Phillips, Lawrence S.
- Pratley, Richard
- Rasouli, Neda
- Robbins, David
- Rosen, Clifford
- Vickery, Ellen M.
- Staten, Myrlene
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-08-08
- Volume
- 381
- Issue
- 6
- Pages
- 520-530
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC6993875
- OpenAlex
- W2948994757
- Cited by
- 673
- References
- 37
- Citations by year
- 2026: 65 · 2025: 65 · 2024: 78 · 2023: 91 · 2022: 105 · 2021: 91 · 2020: 127 · 2019: 50
- FWCI
- 68.54
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Lincoln (University of Nebraska) (submittedVersion)
- Funders
- American Diabetes Association (1-14-D2d-01)
- National Institute of Diabetes and Digestive and Kidney Diseases (U34DK091958)
- Office of Dietary Supplements (U01DK098245)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Vitamin D Research Studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Keywords
- vitamin D supplementation, vitamin D3, type 2 diabetes prevention, prediabetes, 25-hydroxyvitamin D, high-dose vitamin D, glycemic control, new-onset diabetes
- MeSH terms
- Administration, Oral, Aged, Cholecalciferol, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Humans, Male, Middle Aged, Prediabetic State, Risk Factors, Vitamin D, Vitamins, Treatment Failure, Disease-Free Survival, Dietary Supplements, Kaplan-Meier Estimate
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