Evidence map›Paper›PMID 25205139›Full record

Trial reportDiabetes care2014

Rationale and design of the Vitamin D and Type 2 Diabetes (D2d) study: a diabetes prevention trial.

Anastassios G Pittas, Bess Dawson-Hughes, Patricia R Sheehan, Clifford J Rosen, James H Ware, William C Knowler, Myrlene A Staten, D2d Research Group

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
6.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
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  8. Effects of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Prediabetes.The Journal of clinical endocrinology and metabolism · 2022
    Trial
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  12. Vitamin D Supplementation and Prevention of Type 2 Diabetes.The New England journal of medicine · 2019
    Trial
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  16. Review
  17. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Anastassios G PittasDivision of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA.
Bess Dawson-HughesDivision of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA Bone Metabolism Laboratory, Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA.
Patricia R SheehanDivision of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA d2d@tuftsmedicalcenter.org.
Clifford J RosenMaine Medical Center Research Institute, Scarborough, ME.
James H WareDepartment of Biostatistics, Harvard School of Public Health, Boston, MA.
William C KnowlerNational Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.
Myrlene A StatenNational Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.
D2d Research Group
National Institute of Diabetes and Digestive and Kidney Diseases · USTufts Medical Center · USHarvard University · USMaine Medical Center · USTufts University · US

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Leigh Lamonica · 2012 to 2026
$69.1M
Vitamin D and Type 2 Diabetes (D2d)U01DK098245 · NIDDK · TUFTS MEDICAL CENTER · PI PITTAS, ANASTASSIOS G · 2013 to 2020
$45.6M
Primary and Tertiary Prevention of type 2 diabetesZIADK075078 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI HANSON, ROBERT · 2012 to 2025
$4.6M
Vitamin D for Type 2 Diabetes (D2D trial)U34DK091958 · NIDDK · TUFTS MEDICAL CENTER · PI PITTAS, ANASTASSIOS G · 2011 to 2012
$792k
Intramural NIH HHSNIDDK NIH HHS U01 DK098245NIDDK NIH HHS U01-DK-098245NIDDK NIH HHS U34 DK091958NIDDK NIH HHS U34-DK-091958NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

objectiveObservational 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

methodsD2d 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.

conclusionsD2d 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.

Indexed as

Dietary SupplementsAdultAgedBlood GlucoseCholecalciferolDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlycated HemoglobinHumansMaleMiddle AgedPlacebosPrediabetic StateResearch DesignTreatment OutcomeBlood GlucoseCholecalciferolGlycated HemoglobinPlacebos

Identifiers

PMID25205139
PMCPMC4237973
OpenAlexW1968542907

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.