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Vitamin D and Type 2 Diabetes (D2d)

Award Number: U01DK098245
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2013
PERIOD OF PERFORMANCE END DATE: 05/31/2024

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Vitamin D and Type 2 Diabetes (D2d) - Project Summary / Abstract Based on a large body of evidence, vitamin D has emerged as a potential determinant of type 2 diabetes (t2DM) risk. In longitudinal observational studies, higher vitamin D status was associated with up to 83% reduction in the risk of t2DM. However, the evidence to support vitamin D supplementation for prevention of t2DM remains inconclusive. The favorable association between vitamin D status and t2DM risk in observational studies may be confounded by a variety of factors, and long-term, well-designed and adequately powered trials are lacking. The “Vitamin D and type 2 diabetes” (D2d) study is being funded by NIH to provide definitive conclusions regarding the role of vitamin D supplementation for prevention of t2DM. D2d is an ongoing, multicenter, randomized (1:1), double-masked, placebo-controlled, parallel-group, primary prevention clinical trial with two groups (oral 4,000 IU/day of vitamin D3 vs. placebo) among participants at risk for diabetes who are followed for incident diabetes. D2d is designed as an event-driven trial. The study met its enrollment goal in December 2016 and 98% of enrolled participants continue in D2d after a mean follow-up of 19 months. Adherence to study pills is very high (>92% of pills prescribed). The primary aim of the renewal grant is to continue follow- up of the D2d population (N=2,423) and complete the study according to the protocol, which has been approved by the DSMB and all participating IRBs, to answer the study’s primary question: does oral daily vitamin D3 supplementation lower risk of incident diabetes among U.S. adults at high risk for diabetes? Secondary Aims will assess: the heterogeneity of treatment effect of vitamin D supplementation on incident diabetes in subgroups defined by key baseline characteristics (e.g., blood 25-hydroxyvitamin D concentration), effects on secondary outcomes (e.g., blood pressure), and the long-term safety and tolerability of 4000 IU/day of vitamin D3 supplementation. Finally, data from the D2d placebo group will define the natural history of pre- diabetes using the new American Diabetes Association diagnostic criteria that include hemoglobin A1c. The need for a trial such as the D2d study has been recognized in multiple editorials and reviews, including the 2011 Institute of Medicine report on dietary reference intakes for vitamin D, which identified diabetes as one of the most promising non-skeletal outcomes with an urgent need for rigorously conducted trials to confirm the promising results seen in observational and mechanistic studies.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$1 )
2025	2020	TUFTS MEDICAL CENTER PARENT, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	10/8/2024	NON-COMPETING CONTINUATION	-$1
														Subtotal = -$1

Issue Date FY: 2024 ( Subtotal = -$396,013 )
2024	2020	TUFTS MEDICAL CENTER PARENT, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	10/1/2023	NON-COMPETING CONTINUATION	-$377,906
2024	2020	TUFTS MEDICAL CENTER PARENT, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	8	10/1/2023	NON-COMPETING CONTINUATION	-$18,106
														Subtotal = -$396,013

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	6/16/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	1/21/2022	NON-COMPETING CONTINUATION	$0
2022	2020	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	8	4/19/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	2/25/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1 )
2020	2020	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	8	6/2/2020	NON-COMPETING CONTINUATION	$1
2020	2019	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	1/20/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2019	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	7	7/8/2019	NON-COMPETING CONTINUATION	$0
2019	2018	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	6	3/26/2019	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $5,467,912 )
2018	2018	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	6/25/2018	COMPETING CONTINUATION	$5,467,912
2018	2018	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	003	6	9/12/2018	COMPETING CONTINUATION	$4,363,950
2018	2017	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	5	9/12/2018	NON-COMPETING CONTINUATION	-$4,363,950
2018	2017	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	1/17/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $5,467,912

Issue Date FY: 2017 ( Subtotal = $6,550,000 )
2017	2017	TUFTS MEDICAL CENTER, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	6/22/2017	NON-COMPETING CONTINUATION	$6,550,000
														Subtotal = $6,550,000

Issue Date FY: 2016 ( Subtotal = $6,550,000 )
2016	2016	TUFTS MEDICAL CENTER	750 WASHINGTON STREET	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	4/25/2016	EXTENSION WITH OR WITHOUT FUNDS	$6,550,000
														Subtotal = $6,550,000

Issue Date FY: 2015 ( Subtotal = $6,550,000 )
2015	2015	TUFTS MEDICAL CENTER	750 WASHINGTON STREET	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/17/2015	NON-COMPETING CONTINUATION	$6,550,000
														Subtotal = $6,550,000

Issue Date FY: 2014 ( Subtotal = $10,610,574 )
2014	2014	TUFTS MEDICAL CENTER	750 WASHINGTON STREET	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	7/2/2014	NON-COMPETING CONTINUATION	$10,610,574
2014	2014	TUFTS MEDICAL CENTER	750 WASHINGTON STREET	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	7/10/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $10,610,574

Issue Date FY: 2013 ( Subtotal = $9,854,116 )
2013	2013	TUFTS MEDICAL CENTER	750 WASHINGTON STREET	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	5/8/2013	NEW	$9,854,116
														Subtotal = $9,854,116

Grand Total All Awards = $45,186,589

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Vitamin D and Type 2 Diabetes (D2d)

Award Number: U01DK098245

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/01/2013

PERIOD OF PERFORMANCE END DATE: 05/31/2024

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