Effects of the DPP-4 Inhibitor Linagliptin on Heart Failure Outcomes in Patients With Type 2 Diabetes and Cardio-Renal Disease in CARMELINA
Bibliographic record
Abstract
Supplemental vitamin D and marine omega-3 fatty acids have promise for reducing risks of cardiovascular disease (CVD) and cancer, but the evidence remains inconclusive regarding causality.The VITamin D and Omega-A 3 TriaL (VITAL) is a recently completed nationwide, randomized, double-blind, placebo-controlled clinical trial designed to fill this knowledge gap.The study population includes 25,871 U.S. adults (men aged ≥50 and women aged ≥55), without CVD or cancer at baseline, with an oversampling of African Americans (n=5,106).Participants were randomized in a 2x2 factorial design to one of four supplement groups: (1) vitamin D 3 (cholecalciferol; 2000 IU daily) and marine omega-3 fatty acids (Omacor® fish oil, eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA], 1 g daily, ratio of EPA to DHA = 1.3:1); (2) vitamin D and omega-3 placebo; (3) vitamin D placebo and omega-3 fatty acids; or (4) both placebos.The median duration of the randomized treatment period was 5.3 (range 3.8-6.1)years.Randomization was successful, as evidenced by similar distributions of baseline demographic, clinical, and behavioral characteristics across treatment groups.Baseline blood samples were collected from willing participants (n=~17,000), with follow-up blood samples from >6000.Assays for serum 25(OH)D and plasma omega-3 (EPA+DHA) concentrations were performed on baseline and follow-up samples.The primary endpoints of VITAL are: (a) major CVD events (a composite endpoint of MI, stroke, and CVD mortality) and (b) total invasive cancer.Secondary CVD endpoints include: (a) an expanded composite of major CVD events plus coronary revascularization (i.e., coronary artery bypass grafting or percutaneous coronary intervention) and (b) the individual components of the composite CVD endpoints.Secondary cancer endpoints include site-specific cancers and total cancer mortality.In addition, all-cause and cause-specific mortality is ascertained, and monitored safety outcomes include hypercalcemia, parathyroid disorders, and kidney stones.Randomized treatment ended as scheduled at the end of December 2017.VITAL will provide important information on the benefit-risk balance of vitamin D and omega-3 fatty acid supplementation.The principal findings of VITAL, for each intervention and with a particular emphasis on CVD outcomes, will be presented for the first time.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".