Vitamin D and Type 2 Diabetes Study

NCT01942694 | Completed Results DMC

• 1 other identifier: U01DK098245
• Study Type: interventional
• Target: 2,423
• Locations: 1 country
• Sites: 25

Brief Summary

The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.

Conditions

Prediabetes; Type 2 Diabetes

Keywords

Prediabetes; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Time to Development of Diabetes

  New-onset diabetes was based on annual glycemic testing of fasting plasma glucose, glycated hemoglobin, and 2-hour post-load plasma glucose and semiannual testing of fasting plasma glucose and glycated hemoglobin. If two or three of the glycemic measures met the 2010 ADA thresholds for diabetes, the participant was considered to have met the diabetes outcome. When only the measure for fasting plasma glucose or glycated hemoglobin met the threshold, confirmatory testing was performed for the positive measure within 8 weeks. If only the measure for 2-hour post-load plasma glucose met the threshold, then a 75-g oral glucose tolerance test to reassess all three glycemic measures was repeated. If the repeat measure was positive or both fasting plasma glucose and glycated hemoglobin were positive (in the case of a repeat oral glucose tolerance test), than the participant was considered to have met the diabetes outcome.

  Approximately 48 months

Secondary Outcomes (18)

• Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD Concentration

  Approximately 48 months

• Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation)

  Approximately 48 months

• Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria)

  Approximately 48 months

• Variability of Response to Vitamin D Supplementation by Baseline Characteristic: BMI

  Approximately 48 months

• Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist Circumference

  Approximately 48 months

Other Outcomes (8)

• Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Sex

  Approximately 48 months.

• Variability of Response to Vitamin D Supplementation by Baseline Characteristic: Ethnicity

  Approximately 48 months.

• Variability of Response to Vitamin D Supplementation by Baseline Characteristic: 2 Hour Plasma Glucose

  Approximately 48 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One pill daily

Other: Placebo

Vitamin D (Cholecalciferol)

ACTIVE COMPARATOR

One vitamin D pill daily

Dietary Supplement: Vitamin D (Cholecalciferol)

Interventions

Vitamin D (Cholecalciferol) DIETARY_SUPPLEMENT

Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.

Vitamin D (Cholecalciferol)

Placebo OTHER

Administered as one soft-gel pill daily by mouth

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the following glycemic criteria at the baseline visit:
• Fasting plasma glucose (FPG) 100-125 mg/dL
• hour plasma glucose (2hPG) 140-199 mg/dL
• Hemoglobin A1c (HbA1c) 5.7-6.4%
• Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska Native, Native Hawaiian or Other Pacific Islander).
• Body Mass Index ≥ 24.0 (22.5 for Asians) and ≤ 42.0 kg/m2
• Provision of signed and dated written informed consent prior to any study procedures.

You may not qualify if:

• Diabetes based on either of the following criteria:
• 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.
• Meeting the diagnosis criteria for diabetes
• History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.
• Currently breastfeeding.

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Office of Dietary Supplements (ODS): collaborator
• American Diabetes Association: collaborator

Study Sites (25)

Southwest American Indian Center

Phoenix, Arizona, 85016, United States

Location

University of Southern California

Los Angeles, California, 90022, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Orlando VA Medical Center

Orlando, Florida, 32803, United States

Location

Florida Hospital Translational Research Institute

Orlando, Florida, 32804, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66205, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Tulane University Health Sciences

New Orleans, Louisiana, 70112, United States

Location

Maine Medical Center

Scarborough, Maine, 04074, United States

Location

MedStar Community Clinical Research Center

Hyattsville, Maryland, 20782, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Health Partners Riverside Clinic

Minneapolis, Minnesota, 55454, United States

Location

Omaha VA Medical Center

Omaha, Nebraska, 68105, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Duke University

Durham, North Carolina, 27704, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38105, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (11)

• 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.

  PMID: 37104979 DERIVED

• 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.

  PMID: 37001590 DERIVED

• 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: d2d@tuftsmedicalcenter.org. 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.

  PMID: 35753926 DERIVED

• 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.

  PMID: 35140313 DERIVED

• 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.

  PMID: 33693713 DERIVED

• 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.

  PMID: 31965161 DERIVED

• 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.

  PMID: 31173679 DERIVED

• 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.

  PMID: 31007049 DERIVED

• 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.

  PMID: 29941495 DERIVED

• 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.

  PMID: 27899488 DERIVED

• 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.

  PMID: 25205139 DERIVED

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Anastassios Pittas
• Organization: Division of Endocrinology, Diabetes, and Metabolism, Tufts Medical Center

apittas@tuftsmedicalcenter.org

617-636-3232

Study Officials

• Anastassios Pittas, MD, MS

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: September 16, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 16, 2022
• Results First Posted: September 9, 2020

Record last verified: 2022-07

Locations

US (25)