Study Results
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View full resultsBasic Information
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COMPLETED
NA
2423 participants
INTERVENTIONAL
2013-10-31
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
One pill daily
Placebo
Administered as one soft-gel pill daily by mouth
Vitamin D (Cholecalciferol)
One vitamin D pill daily
Vitamin D (Cholecalciferol)
Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.
Interventions
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Vitamin D (Cholecalciferol)
Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.
Placebo
Administered as one soft-gel pill daily by mouth
Eligibility Criteria
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Inclusion Criteria
1. Fasting plasma glucose (FPG) 100-125 mg/dL
2. 2-hour plasma glucose (2hPG) 140-199 mg/dL
3. Hemoglobin A1c (HbA1c) 5.7-6.4%
2. Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska Native, Native Hawaiian or Other Pacific Islander).
3. Body Mass Index ≥ 24.0 (22.5 for Asians) and ≤ 42.0 kg/m2
4. Provision of signed and dated written informed consent prior to any study procedures.
Exclusion Criteria
1. History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes), used for any condition (e.g. pre-diabetes, diabetes, polycystic ovarian syndrome.
2. Meeting the diagnosis criteria for diabetes
2. History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.
3. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.
4. Currently breastfeeding.
30 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Office of Dietary Supplements (ODS)
NIH
American Diabetes Association
OTHER
Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Anastassios Pittas, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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Southwest American Indian Center
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
Orlando VA Medical Center
Orlando, Florida, United States
Florida Hospital Translational Research Institute
Orlando, Florida, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Tulane University Health Sciences
New Orleans, Louisiana, United States
Maine Medical Center
Scarborough, Maine, United States
MedStar Community Clinical Research Center
Hyattsville, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Health Partners Riverside Clinic
Minneapolis, Minnesota, United States
Omaha VA Medical Center
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Beth Israel Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Kaiser Permanente Center for Health Research
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Corbin KD, Pittas AG, Desouza C, Grdinovac KK, Herzig KH, Kashyap SR, Kim SH, Nelson J, Rasouli N, Vickery EM, Knowler WC, Pratley RE. Indices of hepatic steatosis and fibrosis in prediabetes and association with diabetes development in the vitamin D and type 2 diabetes study. J Diabetes Complications. 2023 Jun;37(6):108475. doi: 10.1016/j.jdiacomp.2023.108475. Epub 2023 Apr 12.
Chatterjee R, Davenport CA, Vickery EM, Johnson KC, Kashyap SR, LeBlanc ES, Nelson J, Dagogo-Jack S, Pittas AG, Hughes BD; D2d Research Group. Effect of intratrial mean 25(OH)D concentration on diabetes risk, by race and weight: an ancillary analysis in the D2d study. Am J Clin Nutr. 2023 Jul;118(1):59-67. doi: 10.1016/j.ajcnut.2023.03.021. Epub 2023 Mar 29.
Desouza C, Chatterjee R, Vickery EM, Nelson J, Johnson KC, Kashyap SR, Lewis MR, Margolis K, Pratley R, Rasouli N, Sheehan PR, Pittas AG; D2d Research Group. Electronic address: [email protected]. The effect of vitamin D supplementation on cardiovascular risk in patients with prediabetes: A secondary analysis of the D2d study. J Diabetes Complications. 2022 Aug;36(8):108230. doi: 10.1016/j.jdiacomp.2022.108230. Epub 2022 Jun 12.
Johnson KC, Pittas AG, Margolis KL, Peters AL, Phillips LS, Vickery EM, Nelson J, Sheehan PR, Reboussin D, Malozowski S, Chatterjee R; D2d research group. Safety and tolerability of high-dose daily vitamin D3 supplementation in the vitamin D and type 2 diabetes (D2d) study-a randomized trial in persons with prediabetes. Eur J Clin Nutr. 2022 Aug;76(8):1117-1124. doi: 10.1038/s41430-022-01068-8. Epub 2022 Feb 9.
Chatterjee R, Fuss P, Vickery EM, LeBlanc ES, Sheehan PR, Lewis MR, Dolor RJ, Johnson KC, Kashyap SR, Nelson J, Pittas AG; D2d Research Group. Vitamin D Supplementation for Prevention of Cancer: The D2d Cancer Outcomes (D2dCA) Ancillary Study. J Clin Endocrinol Metab. 2021 Aug 18;106(9):2767-2778. doi: 10.1210/clinem/dgab153.
Hsia DS, Rasouli N, Pittas AG, Lary CW, Peters A, Lewis MR, Kashyap SR, Johnson KC, LeBlanc ES, Phillips LS, Hempe JM, Desouza CV; D2d Research Group. Implications of the Hemoglobin Glycation Index on the Diagnosis of Prediabetes and Diabetes. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e130-8. doi: 10.1210/clinem/dgaa029.
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. Vitamin D Supplementation and Prevention of Type 2 Diabetes. N Engl J Med. 2019 Aug 8;381(6):520-530. doi: 10.1056/NEJMoa1900906. Epub 2019 Jun 7.
Aroda VR, Sheehan PR, Vickery EM, Staten MA, LeBlanc ES, Phillips LS, Brodsky IG, Chadha C, Chatterjee R, Ouellette MG, Desouza C, Pittas AG; D2d Research Group. Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience. Clin Trials. 2019 Jun;16(3):306-315. doi: 10.1177/1740774519839062. Epub 2019 Apr 22.
LeBlanc ES, Pratley RE, Dawson-Hughes B, Staten MA, Sheehan PR, Lewis MR, Peters A, Kim SH, Chatterjee R, Aroda VR, Chadha C, Neff LM, Brodsky IG, Rosen C, Desouza CV, Foreyt JP, Hsia DS, Johnson KC, Raskin P, Kashyap SR, O'Neil P, Phillips LS, Rasouli N, Liao EP, Robbins DC, Pittas AG; D2d Research Group. Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts. Diabetes Care. 2018 Aug;41(8):1590-1599. doi: 10.2337/dc18-0240. Epub 2018 Jun 25.
Lewis MR, Macauley RC, Sheehan PR, Staten MA, Phillips LS, Rasouli N, Pittas AG; D2d Research Group. Management of Hemoglobin Variants Detected Incidentally in HbA1c Testing: A Common Problem Currently Lacking a Standard Approach. Diabetes Care. 2017 Feb;40(2):e8-e9. doi: 10.2337/dc16-1667. Epub 2016 Nov 29. No abstract available.
Pittas AG, Dawson-Hughes B, Sheehan PR, Rosen CJ, Ware JH, Knowler WC, Staten MA; D2d Research Group. Rationale and design of the Vitamin D and Type 2 Diabetes (D2d) study: a diabetes prevention trial. Diabetes Care. 2014 Dec;37(12):3227-34. doi: 10.2337/dc14-1005. Epub 2014 Sep 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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