The Effects of Cholecalciferol Supplementation on FGF23 and α-Klotho in Hemodialysis Patients With Hypovitaminosis D: A Randomized, Double-Blind, Placebo-Controlled Trial.

OBJECTIVE: Vitamin D-fibroblast growth factor-23 (FGF-23)-klotho forms an axis that takes part at least in cardiovascular complications in patients with chronic kidney disease. This study aimed to assess the effects of cholecalciferol supplementation on FGF23 and α-klotho in patients with hypovitaminosis D requiring hemodialysis. METHODS: In a single-center, parallel-arm, randomized, double-blind, placebo-controlled trial, 86 patients with hypovitaminosis D requiring hemodialysis were enrolled. The patients were randomized into 2 groups (n = 43 each) to receive either 50,000 IU of cholecalciferol or placebo every week for 12 weeks. Accordingly, the serum levels of FGF23 and klotho were measured by ELISA and compared between both groups. RESULTS: Serum 25OH(D) levels increased in participants who received cholecalciferol supplementation compared with participants who received placebo (P = .006). In addition, serum FGF23 decreased and α-klotho levels increased in the supplemented group compared with placebo. However, the before-after differences between cholecalciferol supplement and placebo were significant only for α-klotho (P = .035). These effects were not accompanied by changes in the levels of phosphate, total and ionized calcium, and intact parathyroid hormone. CONCLUSION: Cholecalciferol supplementation of 50,000 IU for 12 weeks increases α-klotho levels in the serum of kidney failure patients undergoing hemodialysis. This may suggest that patients receiving maintenance hemodialysis can benefit from using cholecalciferol supplementation and increase in serum α-klotho levels.

Amylose resistant starch (HAM-RS2) supplementation increases the proportion of Faecalibacterium bacteria in end-stage renal disease patients: Microbial analysis from a randomized placebo-controlled trial.

INTRODUCTION: Many of the deleterious effects associated with chronic kidney disease (CKD) are secondary to the resultant systemic inflammation. The gut microbial changes caused by CKD are thought to perpetuate systemic inflammation. Therefore, strategies aimed at modulating the gut microbiota may be helpful in reducing complications associated with CKD. We hypothesized that supplementation with high-amylose maize resistant starch type 2 (HAM-RS2) would beneficially alter the gut microbiome and lead to lower levels of systemic inflammation. METHODS: A double-blind, parallel, randomized, placebo-controlled trial was performed comparing dietary supplementation of HAM-RS2 with placebo in patients with end-stage CKD. Fecal microbial data were obtained from a subset of patients after DNA extraction and 16s sequencing. FINDINGS: Supplementation of HAM-RS2 led to a decrease in serum urea, IL-6, TNFα, and malondialdehyde (P < 0.05). The Faecalibacterium genus was significantly increased in relative abundance following HAM-RS2 supplementation (HAM-RS2-Day 0: 0.40 ± 0.50 vs. HAM-RS2-Day 56: 3.21 ± 4.97 P = 0.03) and was unchanged by placebo (Control-Day 0: 0.72 ± 0.72 vs. Control-Day 56: 0.83 ± 1.57 P = 0.5). DISCUSSION: Supplementation of amylose resistant starch, HAM-RS2, in patients with CKD led to an elevation in Faecalibacterium and decrease in systemic inflammation. Microbial manipulation in CKD patients by using the prebiotic fiber may exert an anti-inflammatory effect through an elevation in the bacterial genera Faecalibacterium.

Comparison of vitamin e and L-carnitine, separately or in combination in patients with intradialytic complications.

BACKGROUND: The most common complications during dialysis are hypotension and muscle cramps. There are many strategies to prevent and treat these complications. OBJECTIVES: The aim of this study is to evaluate effects of vitamin E and L-carnitine supplementation alone and in combination on intradialytic complications. PATIENTS AND METHODS: In a prospective study, 20 patients with end stage renal disease on chronic hemodialysis that had intradialytic complications such as hypotension, muscle cramp, nausea, vomiting and headache were studied. These patients were studied in four 45 day periods, beginning with no treatment (step 1), receiving vitamin E (200 IU/d) (step 2), receiving L-carnitine (500 mg/d) (step 3) and their combination (step 4). Intradialytic complications were recorded in each step and compared between treatments. RESULTS: All three treatments significantly reduced frequency of muscle cramps in comparison to baseline values. Vitamin E alone and in combination with L-carnitine reduced the frequency of muscle cramps more effectively. Hypotension was significantly lower in combination therapy in comparison to baseline values and vitamin E treatment. CONCLUSIONS: Vitamin E and L-carnitine both have comparative effects on intradialytic complications. As the combination use of vitamin E and L-carnitine could more effectively reduce the intradialytic complications, it is recommended for daily use in hemodialysis patients.

Effect of omega-3 supplementation on serum level of homocysteine in hemodialysis patients.

INTRODUCTION: Patients with end-stage renal disease are at a high risk of adverse cardiovascular events. Elevated level of homocysteine is an important risk factor for cardiovascular morbidity and mortality in dialysis patients. There are some strategies for reduction of serum homocysteine level in these patients, including folate and vitamin supplementation. The aim of the present study was to evaluate the effect of omega-3 supplementation on serum homocysteine level in patients on hemodialysis. MATERIALS AND METHODS: In a randomized controlled trial, 100 hemodialysis patients were assigned into two groups to receive omega-3 (oral capsule, 3 g/d) or placebo for 2 months. Complete blood count, blood urea nitrogen, serum creatinine, serum lipids, and serum homocysteine levels were measured before the study and after 2 months at the end of study. RESULTS: Of 100 patients, 6 in each group were excluded, and 44 patients in each group completed the study. There were no significant differences regarding the age, sex, and the number of dialysis sessions per week between the two groups. No difference was observed between the two groups in the laboratory investigations at the end of the study, except for a significant reduction in serum homocysteine level in the omega-3 group as compared to the placebo group (P = .03). CONCLUSIONS: Our study showed a significant reduction regulated by omega-3 supplementation in serum homocysteine level which is a cardiovascular risk factor among hemodialysis patients. Omega-3 can be considered as another homocysteine-reducing agent in this population.