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Article ; Online: Correction to: Safety and tolerability of high-dose daily vitamin D

Johnson, Karen C / Pittas, Anastassios G / Margolis, Karen L / Peters, Anne L / Phillips, Lawrence S / Vickery, Ellen M / Nelson, Jason / Sheehan, Patricia R / Reboussin, David / Malozowski, Saul / Chatterjee, Ranee

European journal of clinical nutrition

2022 Volume 76, Issue 10, Page(s) 1491

Language	English
Publishing date	2022-04-13
Publishing country	England
Document type	Published Erratum
ZDB-ID	639358-5
ISSN	1476-5640 ; 0954-3007
ISSN (online)	1476-5640
ISSN	0954-3007
DOI	10.1038/s41430-022-01130-5
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Article ; Online: Safety and tolerability of high-dose daily vitamin D

European journal of clinical nutrition

2022 Volume 76, Issue 8, Page(s) 1117–1124

Abstract: Background/objectives: Routine use of vitamin D supplements has increased substantially in the United States. However, the safety and tolerability of long-term use of high-dose vitamin D are not known. We assessed the safety and tolerability of high- ... ...

Abstract	Background/objectives: Routine use of vitamin D supplements has increased substantially in the United States. However, the safety and tolerability of long-term use of high-dose vitamin D are not known. We assessed the safety and tolerability of high-dose, daily vitamin D Subjects/methods: In total, 2423 overweight/obese persons with prediabetes were randomized in a double-blind manner to either 4000 IU of vitamin D Results: A total of 8304 AEs occurred during 3 years of follow-up and were less frequent in the vitamin D group compared to placebo (Incidence Rate Ratio [IRR] = 0.94; 95% Confidence Interval (CI) 0.90, 0.98). The overall frequency of protocol-specified AEs of interest, which included nephrolithiasis, hypercalcemia, hypercalciuria, or low estimated glomerular filtration rate, was low and did not differ by group. There were no significant between-group differences in total SAEs (IRR = 0.96 (0.81, 1.14)). Conclusion: Vitamin D Clinical trial registration: ClinicalTrials.gov NCT01942694, prospectively registered September 16, 2013.
MeSH term(s)	Adult ; Cholecalciferol ; Diabetes Mellitus, Type 2/drug therapy ; Dietary Supplements/adverse effects ; Double-Blind Method ; Humans ; Hypercalcemia/chemically induced ; Hypercalcemia/drug therapy ; Hypercalcemia/epidemiology ; Hypercalciuria/chemically induced ; Hypercalciuria/drug therapy ; Nephrolithiasis/chemically induced ; Nephrolithiasis/drug therapy ; Obesity/drug therapy ; Overweight/complications ; Overweight/drug therapy ; Prediabetic State/drug therapy ; Vitamin D ; Vitamins
Chemical Substances	Vitamins ; Vitamin D (1406-16-2) ; Cholecalciferol (1C6V77QF41)
Language	English
Publishing date	2022-02-09
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural
ZDB-ID	639358-5
ISSN	1476-5640 ; 0954-3007
ISSN (online)	1476-5640
ISSN	0954-3007
DOI	10.1038/s41430-022-01068-8
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Article ; Online: The effect of vitamin D supplementation on cardiovascular risk in patients with prediabetes: A secondary analysis of the D2d study.

Desouza, Cyrus / Chatterjee, Ranee / Vickery, Ellen M / Nelson, Jason / Johnson, Karen C / Kashyap, Sangeeta R / Lewis, Michael R / Margolis, Karen / Pratley, Richard / Rasouli, Neda / Sheehan, Patricia R / Pittas, Anastassios G

Journal of diabetes and its complications

2022 Volume 36, Issue 8, Page(s) 108230

Abstract: Aims: Low blood 25(OH)D level is associated with increased cardiovascular disease (CVD) risk. Additionally, individuals with prediabetes are at higher risk for CVD than individuals with normoglycemia. We investigated the effects of vitamin D ... ...

Abstract	Aims: Low blood 25(OH)D level is associated with increased cardiovascular disease (CVD) risk. Additionally, individuals with prediabetes are at higher risk for CVD than individuals with normoglycemia. We investigated the effects of vitamin D supplementation on CVD outcomes in the vitamin D and type 2 diabetes (D2d) study, a large trial among adults with prediabetes. Methods: 2423 participants were randomized to 4000 IU/day of vitamin D Results: Mean age was 60 years, 45 % were women, 13 % had history of CVD. Twenty-one participants assigned to vitamin D and 12 participants assigned to placebo met the MACE outcome (HR 1.81, 95%CI 0.89 to 3.69). There were 27 expanded MACE outcomes in each group (HR 1.02, 95%CI, 0.59 to 1.76). There were no significant differences between vitamin D and placebo in individual CVD risk factors, but change in ASCVD risk score favored the vitamin D group (-0.45 %, 95%CI -0.75 to -0.15). Conclusions: In people with prediabetes not selected for vitamin D insufficiency and with intermediate CVD risk, vitamin D supplementation did not decrease MACE but had a small favorable effect on ASCVD risk score. Trial registration: D2d ClinicalTrials.gov number, NCT01942694, prospectively registered September 16, 2013.
MeSH term(s)	Adult ; Cardiovascular Diseases/epidemiology ; Cardiovascular Diseases/etiology ; Cardiovascular Diseases/prevention & control ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Dietary Supplements ; Double-Blind Method ; Female ; Heart Disease Risk Factors ; Humans ; Male ; Middle Aged ; Prediabetic State/complications ; Prediabetic State/drug therapy ; Prediabetic State/epidemiology ; Risk Factors ; Vitamin D/therapeutic use ; Vitamins/therapeutic use
Chemical Substances	Vitamins ; Vitamin D (1406-16-2)
Language	English
Publishing date	2022-06-12
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Intramural ; Research Support, N.I.H., Extramural
ZDB-ID	1105840-7
ISSN	1873-460X ; 1056-8727
ISSN (online)	1873-460X
ISSN	1056-8727
DOI	10.1016/j.jdiacomp.2022.108230
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Article ; Online: Vitamin D Supplementation for Prevention of Cancer: The D2d Cancer Outcomes (D2dCA) Ancillary Study.

Chatterjee, Ranee / Fuss, Paul / Vickery, Ellen M / LeBlanc, Erin S / Sheehan, Patricia R / Lewis, Michael R / Dolor, Rowena J / Johnson, Karen C / Kashyap, Sangeeta R / Nelson, Jason / Pittas, Anastassios G

The Journal of clinical endocrinology and metabolism

2021 Volume 106, Issue 9, Page(s) 2767–2778

Abstract: Context: Observational studies suggest that low vitamin D status may be a risk factor for cancer.: Objective: In a population with prediabetes and overweight/obesity that is at higher risk of cancer than the general population, we sought to determine ...

Abstract	Context: Observational studies suggest that low vitamin D status may be a risk factor for cancer. Objective: In a population with prediabetes and overweight/obesity that is at higher risk of cancer than the general population, we sought to determine if vitamin D supplementation lowers the risk of cancer and precancers. Methods: The Vitamin D and type 2 diabetes (D2d) cancer outcomes study (D2dCA) is an ancillary study to the D2d study, which was conducted at 22 academic medical centers in the United States. Participants had prediabetes and overweight/obesity and were free of cancer for the previous 5 years. Participants were randomized to receive vitamin D3 4000 IU daily or placebo. At scheduled study visits (4 times/year), cancer and precancer events were identified by questionnaires. Clinical data were collected and adjudicated for all reported events. Cox proportional hazard models compared the hazard ratio (HR) of incident cancers and precancers between groups. Results: Over a median follow-up period of 2.9 years, among 2385 participants (mean age 60 years and 25-hydroxyvitamin D 28 ng/mL), there were 89 cases of cancer. The HR of incident cancer for vitamin D vs placebo was 1.07 (95% CI 0.70, 1.62). Of 241 participants with incident precancers, 239 had colorectal adenomatous polyps. The HR for colorectal polyps for vitamin D vs placebo was 0.83 (95% CI 0.64, 1.07). Conclusion: In the D2d population of participants with prediabetes and overweight/obesity, not selected for vitamin D insufficiency, vitamin D supplementation did not have a significant effect on risk of incident cancer or colorectal polyps.
MeSH term(s)	Aged ; Dietary Supplements ; Female ; Humans ; Male ; Middle Aged ; Neoplasms/prevention & control ; Obesity/complications ; Overweight/complications ; Precancerous Conditions/prevention & control ; Prediabetic State/complications ; Proportional Hazards Models ; Vitamin D/administration & dosage
Chemical Substances	Vitamin D (1406-16-2)
Language	English
Publishing date	2021-03-06
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3029-6
ISSN	1945-7197 ; 0021-972X
ISSN (online)	1945-7197
ISSN	0021-972X
DOI	10.1210/clinem/dgab153
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Article ; Online: Response to Comment on Lewis et al. Management of Hemoglobin Variants Detected Incidentally in HbA

Lewis, Michael R / Sheehan, Patricia R / Staten, Myrlene A / Phillips, Lawrence S / Pittas, Anastassios G

Diabetes care

2016 Volume 40, Issue 10, Page(s) e150–e151

Language	English
Publishing date	2016-02-19
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural ; Comment
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dci17-0020
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Article ; Online: Management of Hemoglobin Variants Detected Incidentally in HbA1c Testing: A Common Problem Currently Lacking a Standard Approach.

Lewis, Michael R / Macauley, Robert C / Sheehan, Patricia R / Staten, Myrlene A / Phillips, Lawrence S / Rasouli, Neda / Pittas, Anastassios G

Diabetes care

2017 Volume 40, Issue 2, Page(s) e8–e9

Language	English
Publishing date	2017-02
Publishing country	United States
Document type	Letter
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc16-1667
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Article ; Online: 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.

Aroda, Vanita R / Sheehan, Patricia R / Vickery, Ellen M / Staten, Myrlene A / LeBlanc, Erin S / Phillips, Lawrence S / Brodsky, Irwin G / Chadha, Chhavi / Chatterjee, Ranee / Ouellette, Miranda G / Desouza, Cyrus / Pittas, Anastassios G

Clinical trials (London, England)

2019 Volume 16, Issue 3, Page(s) 306–315

Abstract: Aims: To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record-supported and conventional recruitment methods.: ... ...

Abstract	Aims: To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record-supported and conventional recruitment methods. Methods: Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record-supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record-supported versus non-electronic health record methods. Results: In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record-supported recruitment was adopted by 21 of 22 sites. Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record-supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level. Conclusion: Establishing electronic health record-supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.
MeSH term(s)	Aged ; Humans ; Middle Aged ; Blood Glucose ; Cholecalciferol/administration & dosage ; Cholecalciferol/therapeutic use ; Comorbidity ; Diabetes Mellitus, Type 2/prevention & control ; Dietary Supplements ; Double-Blind Method ; Electronic Health Records/organization & administration ; Glycated Hemoglobin ; Patient Selection ; Prediabetic State/drug therapy ; Research Design ; Feasibility Studies
Chemical Substances	Blood Glucose ; Cholecalciferol (1C6V77QF41) ; Glycated Hemoglobin
Language	English
Publishing date	2019-04-22
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Observational Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2138796-5
ISSN	1740-7753 ; 1740-7745
ISSN (online)	1740-7753
ISSN	1740-7745
DOI	10.1177/1740774519839062
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Article ; Online: Rationale and design of the Vitamin D and Type 2 Diabetes (D2d) study: a diabetes prevention trial.

Pittas, Anastassios G / Dawson-Hughes, Bess / Sheehan, Patricia R / Rosen, Clifford J / Ware, James H / Knowler, William C / Staten, Myrlene A

Diabetes care

2014 Volume 37, Issue 12, Page(s) 3227–3234

Abstract: Objective: Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a ... ...

Abstract	Objective: Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes. Research design and methods: D2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The final protocol was approved by the D2d Research Group, the data and safety monitoring board, and NIDDK. Key eligibility criteria are age ≥30 years, BMI of 24 (22.5 for Asian Americans) to 42 kg/m(2), increased risk for diabetes (defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [fasting glucose 100-125 mg/dL (5.5-6.9 mmol/L), 2-h postload glucose after 75-g glucose load 140-199 mg/dL (7.7-11.0 mmol/L), hemoglobin A₁c 5.7-6.4% (39-46 mmol/mol)]), and no hyperparathyroidism, nephrolithiasis, or hypercalcemia. D2d participants are randomized to once-daily vitamin D₃ (cholecalciferol 4,000 IU) or placebo and followed for an average of 3 years. The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d. Recruitment was initiated at the end of 2013. Conclusions: D2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes.
MeSH term(s)	Adult ; Aged ; Blood Glucose/drug effects ; Cholecalciferol/administration & dosage ; Diabetes Mellitus, Type 2/prevention & control ; Dietary Supplements ; Double-Blind Method ; Female ; Glycated Hemoglobin A/analysis ; Humans ; Male ; Middle Aged ; Placebos ; Prediabetic State/drug therapy ; Research Design ; Treatment Outcome
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Placebos ; Cholecalciferol (1C6V77QF41)
Language	English
Publishing date	2014-09-09
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural ; Research Support, Non-U.S. Gov't
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc14-1005
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Article ; Online: A community consultation survey to evaluate support for and success of the IMMEDIATE trial.

Beshansky, Joni R / Sheehan, Patricia R / Klima, Kenneth J / Hadar, Nira / Vickery, Ellen M / Selker, Harry P

Clinical trials (London, England)

2014 Volume 11, Issue 2, Page(s) 178–186

Abstract: Background: The IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial, a randomized controlled double-blind clinical effectiveness trial of glucose-insulin-potassium (GIK) administered in ... ...

Abstract	Background: The IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial, a randomized controlled double-blind clinical effectiveness trial of glucose-insulin-potassium (GIK) administered in ambulances in the out-of-hospital setting, used the Exception from Informed Consent Requirements (EFIC) for Emergency Research under Title 21 of the Code of Federal Regulations. EFIC requirements include community consultation that typically involves using a variety of communication methods and venues to inform the public of the research and to receive their feedback. Although not the primary purpose of the community consultation process, a common concern to research sponsors, staff, and institutional review boards (IRBs) is whether there will be a sufficient number of participants to justify mounting a study in their community. Information from community consultation regarding the community acceptance might inform this question. Purpose: We evaluated the utility of telephone survey data done as part of the EFIC process as a way to project the ultimate rate of trial participant enrollment. Methods: A telephone survey community consultation process was undertaken in nine communities planning to be IMMEDIATE Trial sites using a representative sampling of the target population in the areas covered by participating emergency medical service (EMS) agencies. Survey respondents were read a description of the planned study and its informed consent approach that included the option for patients to decline participation in the trial while being transported for acute care in an ambulance. Survey respondents were then asked whether they would object to participating in the study. At the conclusion of actual trial enrollment, the Coordinating Center compared the survey results with the actual rates of enrollment at each site. Results: Approximately 200 (range = 200-271) respondents completed the survey in each of the study communities. Of 2079 survey respondents, 68% (range = 61%-75%) said that they would not object to participating in the trial if experiencing a heart attack, and 85% (range = 79%-89%) said that they would allow the study to be done in their community. During actual trial enrollment in the communities, 79% (range = 63%-91%) of the 828 potential participants agreed in the ambulance to have the study drug started and provided informed consent at the hospital, an average of 13 percentage-points higher than projected by the survey (95% confidence interval (CI): 9%-17%), 19% higher on a relative scale (CI: 14%-25%). Conclusions: The survey-based approach to community consultation proved to be an efficient way to obtain representative input from potential clinical trial participants. The survey data generated a relatively good and conservative estimate of the ultimate rate of trial enrollment. This information could be useful to investigators and IRBs in projecting enrollment for clinical trials using EFIC.
MeSH term(s)	Acute Coronary Syndrome/drug therapy ; Aged ; Community-Based Participatory Research/methods ; Data Collection ; Double-Blind Method ; Emergency Medical Services/methods ; Ethics Committees, Research ; Female ; Glucose/therapeutic use ; Humans ; Hypoglycemic Agents/therapeutic use ; Informed Consent ; Insulin/therapeutic use ; Male ; Middle Aged ; Multicenter Studies as Topic ; Potassium/therapeutic use ; Randomized Controlled Trials as Topic/methods
Chemical Substances	Hypoglycemic Agents ; Insulin ; Glucose (IY9XDZ35W2) ; Potassium (RWP5GA015D)
Language	English
Publishing date	2014-03-29
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	2138796-5
ISSN	1740-7753 ; 1740-7745
ISSN (online)	1740-7753
ISSN	1740-7745
DOI	10.1177/1740774514526476
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Article ; Online: Erratum. 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;41:1590-1599.

LeBlanc, Erin S / Pratley, Richard E / Dawson-Hughes, Bess / Staten, Myrlene A / Sheehan, Patricia R / Lewis, Michael R / Peters, Anne / Kim, Sun H / Chatterjee, Ranee / Aroda, Vanita R / Chadha, Chhavi / Neff, Lisa M / Brodsky, Irwin G / Rosen, Clifford / Desouza, Cyrus V / Foreyt, John P / Hsia, Daniel S / Johnson, Karen C / Raskin, Philip /

Kashyap, Sangeeta R / O'Neil, Patrick / Phillips, Lawrence S / Rasouli, Neda / Liao, Emilia P / Robbins, David C / Pittas, Anastassios G

Diabetes care

2019 Volume 42, Issue 12, Page(s) 2347

Language	English
Publishing date	2019-09-23
Publishing country	United States
Document type	Journal Article ; Published Erratum
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dc19-er12
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