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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.2423 participants were randomized to 4000 IU/day of vitamin DMean 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).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.D2d ClinicalTrials.gov number, NCT01942694, prospectively registered September 16, 2013.

Hypertension control is falling in the US yet efficacious interventions exist. Poor patient reach has limited the ability of pragmatic trials to demonstrate effectiveness. This paper uses quantitative and qualitative data to understand factors influencing reach in Hyperlink 3, a pragmatic hypertension trial testing an efficacious pharmacist-led Telehealth Care intervention in comparison to a physician-led Clinic-based Care intervention. Referrals to both interventions were ordered by physicians.A sequential-explanatory mixed methods approach was used to understand barriers and facilitators to reach. Reach was assessed quantitatively using EHR data, defined as the proportion of eligible patients attending intended follow-up hypertension care and qualitatively, via semi-structured interviews with patients who were and were not reached. Quantitative data were analyzed using descriptive and inferential statistics. Qualitative data were analyzed via combined deductive and inductive content analysis.Of those eligible, 27% of Clinic-based (n = 532/1945) and 21% of Telehealth patients (n = 385/1849) were reached. In both arms, the largest drop was between physician-signed orders and patients attending initial intended follow-up care. Qualitative analyses uncovered patient barriers related to motivation, capability, and opportunity to attend follow-up care.Although the proportion of eligible patients with signed orders was high in both arms, the proportion ultimately reached was lower. Patients described barriers related to the influence of one's own personal beliefs or priorities, decision making processes, logistics, and patient perceptions on physician involvement on reach. Addressing these barriers in the design of pragmatic interventions is critical for future effectiveness.NCT02996565.