Muscle pain, weakness, and other statin-associated muscle symptoms (SAMS) are prevalent and sometimes cause people to stop taking their prescribed statins. While vitamin D therapy has been linked to less statin intolerance in observational research, randomized controlled trials have yet to be reported. The purpose of this study was to examine whether vitamin D supplementation was related to the avoidance of SAMS and the lessening of statin cessation. In a randomized, placebo-controlled, double-blind clinical trial, healthy men and women over 50 and 55 taking no other vitamin D supplements were enrolled. At the beginning of 2016, a survey was administered to those who had begun statin therapy after the randomization process. Early in the year 2022, the data was evaluated. Cholecalciferol (2,000 international units) once a day vs. placebo, with statin prescription monitoring.

Discomfort or soreness in the muscles that last for days (primary outcome) and stop using a statin because of SAMS (secondary outcome). There were 1,033 people randomized to take vitamin D and 1,050 people given a placebo who started taking statins; the average age was 66.8 (6.2), and 49% of the participants were female. Over a median of 4.8 years of follow-up, 317 (31.7%) of those given vitamin D and 325 (31.1%) of those given a placebo both reported SAMS. OR Was 0.97 (95% CI = 0.80-1.18; P=.78) after adjusting for confounders. With an adjusted OR of 1.04 (95% CI, 0.80-1.35; P=.78), 137 people (13%) allocated to vitamin D stopped using statins, while the same number (13%) of those (133) on placebo stopped taking statins. No significant difference in outcomes was seen between pretreatment levels of 25-hydroxy vitamin D (P=.83 for interaction).

With levels below 20 ng/mL, SAMS were reported by 33% of those given vitamin D (28/85) and 35% of those given a placebo (33/95). SAMS was reported by 88/330 vitamin-D assigned subjects (27%), compared to 96/323 placebo recipients (30%). Supplemental vitamin D did not protect against SAMS or lessen statin cessation. The findings held true regardless of the amount of 25-hydroxy vitamin D in the body before therapy.