Vitamin A supplementation is effective for improving the clinical symptoms of urinary tract infections and reducing renal scarring in girls with acute pyelonephritis: a randomized, double-blind placebo-controlled, clinical trial study.

INTRODUCTION: It is believed that tubulointerstitial inflammation plays a role in the formation of renal scarring secondary to acute pyelonephritis (APN). Vitamin A is an anti-inflammatory agent that is involved in the re-epithelialization of damaged mucosal surfaces. OBJECTIVE: The aim of this study was to evaluate the efficacy of vitamin A supplementation in combination with antibiotics for improving urinary tract infections (UTIs) symptoms and preventing renal scarring in girls with APN. STUDY DESIGN: This randomized, double-blind, placebo-controlled clinical trial was conducted on 90 girls aged 2 to 12 years old between 2015 and 2017. Patients with UTIs and first episode of APN diagnosed based on 99 mTc-DMSA scintigraphy (uptake defect) were assessed for eligibility. Patients were randomly divided into two groups that either received 10 days of oral vitamin A (intervention group) or 10 days of placebo (control group) in addition to antibiotics during the acute phase of infection. The clinical response was considered as the primary outcome [duration (positive days) of UTI symptoms during trial treatment period] and secondary outcomes (no change, improving and or worsening of 99 mTc-DMSA scan results 6 months after treatment from baseline). P < 0.05 was considered to be statistically significant. RESULTS: Seventy-four patients (vitamin A group: 36 patients, placebo: 38 patients) were included in the analysis. The mean age was 5.25 ± 1 year old. Three patients (7.89%) in the placebo group and 2 patients (5.55%) in the vitamin A group had vesicoureteral reflux (VUR) (p = 0.114). Duration of fever (vitamin A group: 1.8 days, placebo: 3.1 days, p = 0.0026), urinary frequency (1.3 days vs. 2.8 days, p = 0.003) and poor feeding (2.3 days vs. 4.2 days, p = 0.005) were significantly lower in the vitamin A group. Following the second 99 mTc-DMSA scan, worsening of lesions was observed among 8 (22.2%) and 17 (44.7%) patients in the vitamin A and placebo groups, respectively (p = 0.003). 63.8% (23 patients) of the vitamin A group and 21% (8 patients) of placebo group showed lesion improving in the photopenic region. (P < 0.0001) There was no evidence of vitamin A intolerance. DISCUSSION: Our results show the efficacy of vitamin A supplementation on reducing renal scarring secondary to APN and on fever, urinary frequency and poor feeding duration in girls with APN. CONCLUSION: Vitamin A supplementation is effective for improving the clinical symptoms of UTI and reducing renal injury and scarring following APN in girls with first APN. However, larger randomized clinical trials (RCTs) with longer follow up are needed to confirm these effects.

Use of melatonin versus valproic acid in prophylaxis of migraine patients: A double-blind randomized clinical trial.

BACKGROUND: Melatonin is known to be effective in curing migraine. OBJECTIVE: This study aimed to investigate the therapeutic effect of melatonin versus sodium valproate in the prophylaxis of chronic migraine. METHODS: This randomized, double-blind, placebo-controlled clinical trial included patients with chronic migraine who were divided into three equal sized groups, and baseline therapy with nortriptyline (10-25 mg) and propranolol (20-40 mg) was used. Patients in groups A, B, and C were adjunctively treated daily with 3 mg melatonin, 200 mg sodium valproate, and a placebo, respectively. The patients underwent treatment for 2 months and follow-up was done at baseline (baseline), first (I) and second month (II). Attack frequency (AF), attack duration, attack severity, Migraine Disability Assessment (MIDAS) score (within 3 months in two steps), analgesic intake, and drug side effects between the groups and during follow-up were compared. RESULTS: The mean of monthly AF (melatonin: baseline: 4.2, I: 3.1, II: 2.5, p = 0.018; valproate: baseline: 4.3, I: 3.1, II: 2.3, p = 0.001; placebo: baseline: 4.1, I: 3.8, II: 3.8 p = 0.211), attack duration (hr) (melatonin: baseline: 19.8, I: 10.1, II: 8.7, p < 0.001; valproate: baseline: 19.5, I: 10.2, II: 8.8, p < 0.001; placebo: baseline: 19.6, I: 15.4, II: 14.1, p = 0.271), attack severity (melatonin: baseline: 7.3, I: 5.4, II: 3.5, p < 0.001; valproate: baseline: 7.4, I: 5.3, II: 3.4, p = 0.000; placebo: baseline: 7.3, I: 6.4, II: 6, p = 0.321), and MIDAS score (melatonin: baseline: 15.2, II: 8.9, p = 0.005; valproate: baseline: 16.1, II: 8.3, p = 0.001; placebo: baseline: 16, II: 12.1, p = 0.44), were significantly reduced in the melatonin and sodium valproate groups, but not in the placebo groups. Adverse events were reported in 11 patients (10.47%): 2 (5.71%) during melatonin treatment, 8 (22.85%) during valproate, and 1 (2.85%) during placebo. CONCLUSION: The adjuvant treatment with melatonin was found to be superior to the placebo and had the same clinical efficacy as sodium valproate, but with higher tolerability. Melatonin may prove to be an efficient substitute for sodium valproate, as a chronic migraine prophylaxis.

Oral Zinc Sulfate as Adjuvant Treatment in Children With Nephrolithiasis: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

BACKGROUND: Nephrolithiasis in children is associated with a high rate of complications and recurrence. OBJECTIVES: Since some evidences reported that zinc has an important place amongst inhibitors of crystallization and crystal growth, we decided to assess the effectiveness of oral zinc sulfate as adjuvant treatment in children with nephrolithiasis. PATIENTS AND METHODS: This was a randomized, double-blind, placebo-controlled clinical trial. 102 children in the age range 1 month to 11 years with first nephrolithiasis were recruited. Patients were randomly divided into two equal groups (intervention and control groups). Intervention group received conservative measures for stones and 1 mg/kg/day (maximum 20 mg/day) oral zinc sulfate syrup for 3 months. Control group received placebo in addition to conservative measures, also for 3 months. Patients were followed up by ultrasonography for 9 months, in 5 steps (at the end of 1st, 2nd, 3rd, 6th and 9th month after treatment) assessing size and number of stones in the kidneys. RESULTS: Only at the end of the first month, the average number (intervention: 1.15 ± 3.78, control: 1.3 ± 2.84) (P = 0.001) and size (cm) (intervention: 0.51 ± 1.76, control: 0.62 ± 1.39) (P = 0.001) of stones was significantly lower in the intervention group, and in other points there was no significant therapeutic efficacy in oral zinc adjuvant treatment compared to conservative treatment alone. Also, during the 9-month follow-up, the number and size of stones in both groups decreased significantly (both: P < 0.0001) in a way that the decrease in the intervention group showed no difference with the control group. CONCLUSIONS: Adjuvant treatment with zinc is not more effective than consecutive treatment in children with nephrolithiasis. However, further studies are recommended due to the lack of clinical evidence in this field.

Vitamin E as adjuvant treatment for urinary tract infection in girls with acute pyelonephritis.

INTRODUCTION: Vitamin E is a fat-soluble vitamin that functions as an antioxidant. The aim of this study was to investigate the effects of vitamins E supplementation in combination with antibiotics for the treatment of girls with acute pyelonephritis. MATERIALS AND METHODS: This double-blinded randomized controlled trial was conducted on 152 girls aged 5 to 12 years with a first acute pyelonephritis episode based on technetium Tc 99m dimercaptosuccinic acid (99mTc-DMSA). They were randomized to receive a 14-day treatment with only antibiotics (control group; n = 76) and 14-day treatment with supplements of vitamin E (intervention group; n = 76) in addition to the antibiotics. Patients' clinical symptoms were monitored for 14 days and urine culture was performed 3 to 4 days and 7 to 10 days after the start of the treatment and its completion, respectively. All of the girls once underwent DMSA scan 4 to 6 months after the treatment. RESULTS: During the follow-up days, the mean frequency of fever (P = .01), urinary frequency (P = .001), urgency (P = .003), dribbling (P = .001), and urinary incontinence (P = .006) were significantly lower in the intervention group compared to the control group. There was no significant difference in the results of urine culture 3 to 4 days after the start of treatment (P = .16) and 7 to 10 days after its termination (P = .37). There was also no significant difference between the results of DMSA scan 4 to 6 months after the start of treatment (P = .31). CONCLUSIONS: Vitamin E supplementation has a significant effect in ameliorating sign and symptoms of UTI. However, further studies are recommended to confirm these findings.