Xiao Fei Qin1, Luo Sha Zhao2, Wei Ren Chen3, Da Wei Yin3, Hao Wang3. 1. Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Henan Province, China. 2. Department of Cardiology, the First Affiliated Hospital of Zhengzhou University, Henan Province, China. Electronic address: zhaoluosha@126.com. 3. Department of South-building Cardiology, PLA General Hospital at Beijing, China.
Abstract
BACKGROUND & AIMS: Lipid abnormalities are regarded as a risk factor for cardiovascular disease. Low vitamin D status has been shown to be associated with hyperlipidemia. We planned to research the effects of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia. METHODS:Patients with hypercholesterolemia were enrolled in this single-center, double-blind, placebo-controlled trial in Beijing (39°54' N). Fifty-six patients were randomly assigned to receive vitamin D (n = 28, 2000 IU/d) or a placebo (n = 28) as an add-on to statin, by the method of permutated block randomization. Serum lipid levels were evaluated at baseline, 1, 3 and 6 months. RESULTS:Vitamin D supplementation resulted in increased serum 25-hydroxyvitamin D concentrations compared with placebo (+16.3 ± 11.4 compared with +2.4 ± 7.1 ng/ml; p < 0.001). At 6 months, the primary end point, a difference in the fall of serum total cholesterol levels between the vitamin D and placebo groups after 6 months of treatment was significant -22.1 mg/dl (95% CI -32.3; -12.2) (p < 0.001). The difference between the groups in the fall of serum triglyceride levels after 6 months of treatment was -28.2 mg/dl (95% CI -48.8; -8.4) (p < 0.001). In patients with 25-hydroxyvitamin D level<30 ng/ml at baseline (n = 43), the serum total cholesterol and triglyceride levels were reduced by -28.5 ± 11.9 mg/dl (p < 0.001) and -37.1 ± 19.5 mg/dl (p < 0.001), respectively. CONCLUSIONS:Vitamin D supplementation might improve serum lipid levels in statin-treated patients with hypercholesterolemia, it might be an adjuvant therapy for patients with hypercholesterolemia. Clinical Trials Registration Number - NCT02009787.
RCT Entities:
BACKGROUND & AIMS:Lipid abnormalities are regarded as a risk factor for cardiovascular disease. Low vitamin D status has been shown to be associated with hyperlipidemia. We planned to research the effects of vitamin D supplementation as an adjuvant therapy for patients with hypercholesterolemia. METHODS:Patients with hypercholesterolemia were enrolled in this single-center, double-blind, placebo-controlled trial in Beijing (39°54' N). Fifty-six patients were randomly assigned to receive vitamin D (n = 28, 2000 IU/d) or a placebo (n = 28) as an add-on to statin, by the method of permutated block randomization. Serum lipid levels were evaluated at baseline, 1, 3 and 6 months. RESULTS:Vitamin D supplementation resulted in increased serum 25-hydroxyvitamin D concentrations compared with placebo (+16.3 ± 11.4 compared with +2.4 ± 7.1 ng/ml; p < 0.001). At 6 months, the primary end point, a difference in the fall of serum total cholesterol levels between the vitamin D and placebo groups after 6 months of treatment was significant -22.1 mg/dl (95% CI -32.3; -12.2) (p < 0.001). The difference between the groups in the fall of serum triglyceride levels after 6 months of treatment was -28.2 mg/dl (95% CI -48.8; -8.4) (p < 0.001). In patients with 25-hydroxyvitamin D level<30 ng/ml at baseline (n = 43), the serum total cholesterol and triglyceride levels were reduced by -28.5 ± 11.9 mg/dl (p < 0.001) and -37.1 ± 19.5 mg/dl (p < 0.001), respectively. CONCLUSIONS:Vitamin D supplementation might improve serum lipid levels in statin-treated patients with hypercholesterolemia, it might be an adjuvant therapy for patients with hypercholesterolemia. Clinical Trials Registration Number - NCT02009787.
Authors: Arrigo F G Cicero; Alessandro Colletti; Gani Bajraktari; Olivier Descamps; Dragan M Djuric; Marat Ezhov; Zlatko Fras; Niki Katsiki; Michel Langlois; Gustavs Latkovskis; Demosthenes B Panagiotakos; Gyorgy Paragh; Dimitri P Mikhailidis; Olena Mitchenko; Bernhard Paulweber; Daniel Pella; Christos Pitsavos; Željko Reiner; Kausik K Ray; Manfredi Rizzo; Amirhossein Sahebkar; Maria-Corina Serban; Laurence S Sperling; Peter P Toth; Dragos Vinereanu; Michal Vrablík; Nathan D Wong; Maciej Banach Journal: Arch Med Sci Date: 2017-08-04 Impact factor: 3.318