Reduction of Some Atherogenic Indices in Patients with Non-Alcoholic Fatty Liver by Vitamin D and Calcium Co-Supplementation: A Double Blind Randomized Controlled Clinical Trial.

The role of non-alcoholic fatty liver disease (NAFLD) as a potential independent cardiovascular disease (CVD) risk factor has recently gained considerable attention because CVD is the common cause of death in NAFLD patients. We aimed to estimate the effects of vitamin D supplementation alone or in combination with calcium on atherogenic indices, liver function tests, and grade of disease in patients with NAFLD. One-hundred twenty NAFLD patients were randomized in a double-blind, placebo-controlled clinical trial as follows: D (1000 IU vitamin D), CaD (500 mg as calcium carbonate plus 1000 IU vitamin D) or P (placebo), once daily with meals over 12 weeks. Adjusted for all the baseline measures, reduction in serum ALT, AST, LDL-C/HDL-C, TC/HDL-C, and non-HDL-C were significantly higher in the CaD compared with the P group (p < 0.001, p = 0.03, p < 0.001, p < 0.001, p < 0.001 and p < 0.001, respectively). Also, mean difference of serum ALT, LDL-C/HDL-C, TC/HDL-C, and TG/HDL-C were significantly higher in the CaD than D group (p < 0.001, p = 0.006, p < 0.001 and p = 0.03, respectively). Serum non-HDL-C was marginally decreased in the CaD compared with the D group (p = 0.06). With considering the BMI changes as covariate, reduction in the grade of fatty liver was significantly higher in the CaD and D groups than the P (p < 0.001). The present study suggests that supplemental calcium combined with vitamin D, but not vitamin D alone, may reduce serum atherogenic indices, liver function tests, and grade of disease in patients with NAFLD.

Effect of daily calcitriol supplementation with and without calcium on disease regression in non-alcoholic fatty liver patients following an energy-restricted diet: Randomized, controlled, double-blind trial.

BACKGROUND & AIMS: Despite evidence for beneficial effects of vitamin D, to our knowledge, no study has compared the effects of calcium supplementation with vitamin D on non-alcoholic fatty liver disease (NAFLD) regression during a hypo-energetic program. We compared the effect of the vitamin D supplementation with and without calcium on anthropometric measures and biochemical parameters in NAFLD patients during a weight-loss program. METHODS: A 12-week, randomized, controlled, double-blind trial was conducted in 120 NAFLD patients randomly assigned to receive 25 µg calcitriol (n = 37), 500 mg calcium carbonate + 25 µg calcitriol (n = 37), or placebo (n = 36) every day with their lunch meals while following a weight-loss program. RESULTS: Weight, BMI and fat mass reduction were significant in each group after 12 wk of intervention (p < 0.001), but differences among the groups was not significant after 12 wk of the study, adjusted to the baseline measurements. Significant reduction in fasting plasma glucose (FPG), insulin, insulin resistance (by HOMA-IR) and TG concentrations and an increase in HDL.C was seen over the 12 wk of study in each group (p < 0.001). Adjusting to the baseline measurements, there was significant difference in FPG (p < 0.001), HOMA-IR (p < 0.001), serum insulin (p = 0.01), TG (p = 0.01) and HDL.C (p < 0.001) among the groups after 12 wk of the study. The calcium plus calcitriol group showed a significant decrease in ALT and FPG and increase in HDL.C level compared with the calcitriol group, adjusted to the baseline measures (p < 0.001). CONCLUSIONS: Our results suggest that calcium plus calcitriol supplementation for 12 weeks may be potentially effective for biochemical parameters in NAFLD patients. Further additional larger controlled trials are needed to confirm these findings. REGISTRATION: Registered under ClinicalTrials.gov Identifier no. IRCT201408312709N29.

Regression of Non-Alcoholic Fatty Liver by Vitamin D Supplement: A Double-Blind Randomized Controlled Clinical Trial.

OBJECTIVE: Evidence indicates that NAFLD patients are vitamin D deficient. Vitamin D has new roles in lipid and glucose metabolism. The aim of this study was to examine the effects of calcitriol supplementation on the NAFLD progression based on liver lipid accumulation, serum lipid profile and insulin resistance. METHODS: We randomly assigned 73 patients with NAFLD-confirmed by ultra-sonography to 12 weeks of treatment with hypocaloric diet (reduction of 500 kcal per day) plus 25 µg of calcitriol supplement or a hypocaloric diet plus placebo. Before and after treatment, we assessed anthropometric parameters, grade of fatty liver, serum lipoproteins, liver enzymes and insulin level. RESULT: Baseline variables were not significantly different between groups. A statistically significant reduction in anthropometric measures was observed over the 12 weeks in both groups. However, no significant differences were seen between groups after intervention. Compared with the placebo, reductions in triglyceride and an increase in HDL cholesterol were seen over the 12 weeks of intervention in the calcitriol group (P = 0.002 and P = 0.004). AST level was decreased in the calcitriol group (-4.2 ± 4.3 µmol/L, P < 0.001), but increased in the placebo group (12.6 ± 6.1 µmol/L, P = 0.02) after 12 weeks. Reductions in mean difference of ALT, insulin and HOMA were significantly higher in the calcitriol than placebo group (P = 0.01, P = 0.007 and 0.01). CONCLUSIONS: Calcitriol supplementation combined with weight loss diet showed no significant effects on anthropometric measures in NAFLD patients. However, it may have positive effects on lipid profile, liver enzyme tests and insulin sensitivity during a weight-loss program.