Effect of Vitamin D Supplementation on Vitamin D Level and Bone Mineral Density in Patients With Cirrhosis: A Randomized Clinical Trial

Abstract

Introduction: In patients with cirrhosis, highly prevalent vitamin D deficiency and low bone mineral density (BMD) increase the burden of disease, and role of vitamin D supplementation is not clear. So, our aim was to determine the effect of vitamin D supplementation on vitamin D level and BMD in patients with cirrhosis. Methods: Patients with cirrhosis (18–60 years) of any etiology were enrolled. We measured serum 25(OH)D, parathyroid hormone, thyroid-stimulating hormone, free T4, bone-specific alkaline phosphatase, insulin-like growth factor (IGF)-1, and health-related quality of life at entry and at 1 year; however, serum calcium was measured at 3-month interval. BMD was measured by dual-energy x-ray absorptiometry at lumbar spine and left hip neck at entry and after 1 year. Statistical analysis was performed according to intention-to-treat analysis. Results: Of 390 screened patients with cirrhosis, 164 participants (82 in each group) were randomized. There was significant increase in 25(OH)D levels in intervention group after 1 year (33.7 [24.3–45.7] ng/mL vs 23.1 [17–28.2] ng/mL; P < 0.001) when compared with placebo. The mean difference in BMD at lumbar spine and left hip neck was not significantly changed after 1 year of intervention with vitamin D between both groups. There was no significant change in both the groups in levels of calcium, thyroid-stimulating hormone, parathyroid hormone, free T4, IGF-1, and bone-specific alkaline phosphatase and quality of life. Discussion: Supplementation with vitamin D for 1 year improves vitamin D levels but did not result in improvement in BMD at lumbar spine and left hip neck in patients with cirrhosis.

Response to Medda et al.

“…Increase in serum 25[OH]D lowers parathyroid hormone levels ( 4), but in our study, serum parathyroid hormone levels did not differ between intervention and placebo groups at baseline and 1 year (Table 4) (2). There are multiple variables that affect bone mineral density other than vitamin D 3 supplementation.…”

“…We thank Medda et al for their interest in our article and raising important questions about the study (1,2). We agree with this important observation that there is an increase in serum 25[OH]D after 1 year in the treatment arm and in the placebo arm.…”

Overview of Complications in Cirrhosis

“…85 The role of oral vitamin D supplementation has been described in a recent trial wherein mean difference in BMD at lumbar spine and left hip neck did not differ after 1 year of intervention, albeit with significant improvement in vitamin D levels. 130 Also, a Cochrane meta-analysis suggested a low level of evidence regarding prevention of liver-related morbidity or decompensation. The authors assessed the efficacy of vitamin D vs. placebo or no intervention in 27 trials with 979 participants with a mean follow-up of 7 months and showed reduced risk ratio (0.86, 95% CI 0.51 to 1.45) of all-cause mortality).…”

Response to Grover et al.

“…We read with great interest the article published by Grover et al (1) in the October issue of The American Journal of Gastroenterology . The study investigated the effect of oral vitamin D supplementation on serum vitamin D levels and bone mineral density (BMD) in patients with cirrhosis.…”