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.
Subject(s)
Cholesterol/blood , Dietary Supplements , Hypercholesterolemia/drug therapy , Triglycerides/blood , Vitamin D/blood , Vitamin D/therapeutic use , Aged , Anticholesteremic Agents/administration & dosage , Double-Blind Method , Female , Follow-Up Studies , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Hypercholesterolemia/blood , Male , Middle Aged , Treatment Outcome , Vitamin D/administration & dosageABSTRACT
OBJECTIVES: Low vitamin D status has been shown to be associated with hypertension. We planned to research the effect of vitamin D and nifedipine in the treatment of patients with essential hypertension. METHODS: Patients with grades I-II essential hypertension were enrolled in this single-center, double-blind, placebo-controlled trial in Beijing. All patients received a conventional antihypertensive drug (nifedipine, 30 mg/d). One hundred and twenty-six patients were randomly assigned to receive vitamin D (n=63, 2000 IU/d) or a placebo (n=63) as an add-on to nifedipine, by the method of permutated block randomization. Ambulatory blood pressure monitoring was performed at baseline (month 0), at month 3 and at month 6. RESULTS: In vitamin D supplementation group, there was a significant increase in mean 25-hydroxyvitamin D levels from baseline (19.4 ± 11.6 ng/ml) to 6 months (34.1 ± 12.2 ng/ml; p<0.001). At 6 months, the primary end points, a difference in the fall of 24-h mean blood pressure, between the groups was -6.2 mmHg (95% CI -11.2; -1.1) for systolic blood pressure (p<0.001) and -4.2 mmHg (95% CI -8.8; -0.3) for diastolic blood pressure (p<0.001) under intention to treat analysis. In patients with vitamin D <30 ng/ml at baseline (n=113), 24-h mean blood pressure decreased by 7.1/5.7 mmHg (p<0.001). Safety and tolerability were similar among the two groups. CONCLUSIONS: Vitamin D supplementation can reduce blood pressure in patients with hypertension, it can be an adjuvant therapy for patients with grades I-II essential hypertension. CLINICAL TRIAL REGISTRATION: This study was registered in the Chinese Clinical Trial Registry, it is available in Website: http://www.chictr.org/cn/; REGISTRATION NUMBER: ChiCTR-ONC-13003840.