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To our knowledge, no randomized study has shown whether zinc replacement therapy is effective for hyperammonemia in liver cirrhosis; therefore, we performed a double-blind, placebo-controlled trial to examine efficacy and safety of the zinc replacement therapy. Patients with liver cirrhosis and hyperammonemia (at or above the institutional reference value) and hypozincemia (≤65 μg/dL) were enrolled in the outpatient units of the participating institutions and were randomly divided to receive placebo (P group) or zinc acetate preparation at a dose of 3 capsules/d for a total zinc content of 150 mg/d (Z group) by the envelope method. Of the 18 enrolled patients, 6 dropped out; thus, the analyses included 12 patients (5 in the P group and 7 in the Z group). Variations in blood concentrations of zinc and ammonia as well as liver function test results were compared. Blood zinc levels significantly increased in the Z group (P = 0.0037; Friedman test) but not the P group. Blood ammonia levels significantly decreased in the Z group (P = 0.0114; Friedman test) but not the P group. The percent change in blood ammonia level also revealed significant reduction at the eighth week in the Z group (P = 0.0188: Mann-Whitney test). No serious adverse events attributable to the zinc preparation were noted. Although this study is preliminary and includes a small sample, it is, to our knowledge, the first randomized controlled trial to show that zinc supplementation for 3 mo seems effective and safe for treating hyperammonemia in liver cirrhosis. Studies with a larger sample size are needed to confirm our findings.

Background: In hemodialysis (HD) patients, zinc depletion caused by inadequate intake, malabsorption, and removal by HD treatment leads to erythropoiesis-stimulating agent (ESA) hyporesponsiveness. This study investigated the effects of zinc supplementation in HD patients with zinc deficiency on changes in the erythropoietin responsiveness index (ERI). Methods: Patients on HD with low serum zinc levels (<65 μg/dL) were randomly assigned to two groups: The polaprezinc group (who received daily polaprezinc, containing 34 mg/day of zinc) (n = 35) and the control group (no supplementation) (n = 35) for 12 months. All the 70 patients had been taking epoetin alpha as treatment for renal anemia. ERI was measured with the following equation: Weekly ESA dose (units)/dry weight (kg)/hemoglobin (g/dL). Results: There were no significant changes in hemoglobin levels within groups or between the control and polaprezinc groups during the study period. Although reticulocyte counts were increased immediately after zinc supplementation, this change was transient. Serum zinc levels were significantly increased and serum copper levels were significantly decreased in the polaprezinc group after three months; this persisted throughout the study period. Although there was no significant change in the serum iron or transferrin saturation levels in the polaprezinc group during the study period, serum ferritin levels significantly decreased following polaprezinc treatment. Further, in the polaprezinc group, ESA dosage and ERI were significantly decreased at 10 months and nine months, respectively, as compared with the baseline value. Multiple stepwise regression analysis revealed that the change in the serum zinc level was an independent predictor of lowered ERI. Conclusions: Zinc supplementation reduces ERI in patients undergoing HD and may be a novel therapeutic strategy for patients with renal anemia and low serum zinc levels.

Background Low-osmolarity oral rehydration salt (ORS) and zinc therapy effectively manage diarrhea in children under five years of age, offering both short- and long-term benefits. Despite this, caregivers’ adherence to ORS and zinc is often unsatisfactory due to factors such as forgetfulness, resolution of symptoms, and underestimation of the disease’s severity. This study assessed the effect of mobile call reminders on ORS and zinc tablet adherence among children with acute diarrhea in a secondary-level health facility in Kwara State, Nigeria. Methods Using an open-label, randomized controlled trial design, this study compared caregiver-child pairs with acute diarrhea aged 6–59 months who received standard instructions (SI) alone (control group) and an intervention group (IG) who received SI plus phone call reminders on days three and seven of zinc sulfate therapy. All participants used a pictorial diary to track loose/watery stools and ORS and zinc tablet treatments for ten days. The primary outcome measures were independent and combined adherence to ORS and zinc therapy. The secondary outcomes were independent and combined adherence scores, defined as the percentage of times the ORS was given post-diarrhea and the percentage of prescribed zinc tablets administered out of ten. Results A total of 364/400 mother–child pairs completed the study. The percentage of mothers with full adherence in the intervention group was 82.5% for ORS, 72.1% for zinc, and 58.5% for combined use, compared to 78.8%, 60.8%, and 43.6%, respectively, in the control group. The odds of full adherence to ORS and zinc were 1.6 and 1.7 times higher among intervention mothers [ORS: OR = 1.561, 95% CI = 0.939–2.598, P  = 0.085; zinc: OR = 1.671, 95% CI = 1.076–2.593, P  = 0.022], and 1.8 times higher for combined use according to WHO guidelines [OR = 1.818, 95% CI = 1.200–2.754, P  = 0.005]. The mean adherence scores for the intervention group were higher than those for the control group by 4.1% (95% CI = 0.60–7.60) for ORS, 7.3% (95% CI = 3.74–10.86) for zinc, and 5.7% (95% CI = 3.23–8.17) for the combined treatment. Conclusion Phone reminders can effectively improve consistency of home treatment administered by caregivers for children under five years old. Trial Registration The study was registered retrospectively (17/3/2023) with the Pan African Clinical Trial Registry (PACTR202301560735856).

Objectives To evaluate the efficacy of a toothpaste containing amine compound, 0.5% zinc lactate, and 1400 ppm F (NaF) in comparison to a regular fluoride toothpaste containing 1450 ppm F as MFP/NaF (negative control). Plaque and gingivitis indices were determined over a 6-month period. Materials and methods In a randomized, double-blind, two-cell, parallel-group design on healthy adults from the Bangkok, Thailand area presenting with initial gingivitis (Löe-Silness gingival index ≥ 1) and visible plaque (Turesky Modification-Quigley-Hein index ≥ 1.5) were assigned test and negative control toothpastes and instructed to brush twice daily for two minutes. Results Site-level ( N  = 10,778) and subject-level ( N  = 92) data indicated that the test toothpaste increased the number of healthy sites and improved gum health as compared to the negative control toothpaste. For the test group, after 6 months, the average reduction for plaque, gingival index, and gingival severity was 31.2%, 32.3%, and 49.3%, respectively. Average reductions were greater in the test group than the negative control group across all measures. Conclusions The amine + zinc + fluoride toothpaste significantly improved measures of plaque (12× more effective) and gingivitis (5× more effective) in comparison to a standard fluoride toothpaste, suggesting that the novel formulation with antibacterial active ingredients amine and zinc facilitates more effective plaque removal, and promotes gingival health. Clinical relevance These results suggest that daily use of amine + zinc + fluoride toothpaste can provide a significant improvement in managing plaque accumulation and bleeding associated with gingival inflammation especially for patients experiencing gingivitis. Clinical trial registration NCT06563518 (registration date: August 19, 2024).

Background Enterohepatic bilirubin circulation is one of the determinants of neonatal jaundice. Objective To evaluate the role of oral zinc in reducing serum bilirubin in term neonates with hyperbilirubinemia. Study design Double-blind, randomized, placebo-controlled trial Participants 106 term neonates with jaundice within the phototherapy range admitted to a level III neonatal intensive care unit. Intervention Neonates were randomized and allocated to receive either oral zinc sulfate (5 mg/day) or matching placebo for 5 days. Both groups received conventional phototherapy as per American Academy of Pediatrics (AAP) guidelines. Outcomes Primary : Reduction in total serum bilirubin levels at 24, 48, 72, and 96 hr after intervention. Secondary : Duration of phototherapy, and hospital stay. Results The mean (SD) total serum bilirubin levels in zinc and placebo groups were 15.3 (2.85) vs 17.1 (2.21) mg/dL (MD 1.74; P <0.001) at 24 h; 11.7 (4.46) vs. 14.62 (3.83) mg/dL (MD 2.89; P <0.001) at 48 h; 6.7 (4.77) vs 9.5 (3.70) mg/dL (MD 2.79; P <0.001) at 72 h; and 5.1 (3.95) vs 6.5 (3.70) mg/dL (MD 1,49; P =0.045) after 72 hr, respectively. The mean (SD) duration of phototherapy was significantly lower in zinc group than placebo group [53.42 (19.62) vs 71.4 (19.43) h; P <0.001]. There was no significant difference in hospital stay between the two groups [mean (SD) 81.05 (19.43) vs 86.25 (20.02) h; P = 0.227]. Conclusion Oral zinc sulfate supplementation at a dose of 5 mg once a day along with phototherapy significantly reduced total and indirect serum bilirubin levels and also reduced the total duration of phototherapy required in the term neonatal hyperbilirubinemia, with minimal or no adverse effects.

Background A significant percentage of head and neck cancer (HNCs) patients receiving RT experience oral mucositis (OM). This study aimed to evaluate the effect of the polyherbal (containing chamomile, peppermint oil, Aloe vera , and honey) and zinc mouthwashes in comparison to the control (chlorhexidine) and placebo groups for prevention of radiation-induced OM. Methods This study was a double-blinded randomized clinical trial, conducted on 67 patients with HNCs undergoing radiotherapy. The eligible participants were randomized to receive either one of the following; zinc sulfate, polyherbal, chlorhexidine (Vi-one 0.2% CHX), or placebo mouthwash for 6 weeks. Follow-up evaluation of oral hygiene and the checklists of OM and the intensity of pain were filled out according to WHO assessment tool, Oral Mucositis Assessment Scale (OMAS), and Visual Analog Scale (VAS) in all the participants weekly for seven consecutive weeks. Results The results of present clinical trial demonstrated that the use of either zinc sulfate or polyherbal mouthwash significantly reduced the scores of OM and the severity of pain during weeks 2 to 7 after consumption compared with the CHX or placebo mouthwashes ( P  < 0.05). According to the post hoc analysis and compared with the placebo, a significantly better result was reported for zinc sulfate and polyherbal mouthwashes at weeks 2 to 7, but not for the CHX mouthwash. Conclusion This study showed that the use of zinc sulfate or polyherbal mouthwashes is effective in prevention of both OM severity scores and pain related to OM intensity at weeks 2 to 7 following consumption in HNCs patients. Trial registration IRCT20190123042475N1 and IRCT20190123042475N2. Registration date: 2019-06-09, 2019-07-26.

Objectives To determine the efficacy of zinc sulfate supplementation in managing dysmenorrhoea. Methods In total, 103 high school students were randomised into an experimental arm (52 students) and a control arm (51 students) and received 40-mg zinc sulfate or placebo, respectively, over three cycles. Primary outcome measures were the mean Visual Analogue Scale score, which measured pain over three cycles, and the frequency of nausea and vomiting. Secondary outcomes were the use of additional analgesics and the frequency of allergic reactions. Results Fifty participants were analysed in each group. Mean pain scores were not significantly different between the groups before administering zinc sulfate therapy. Following the intervention, the mean pain scores for the treatment (2.80 ± 2.28) and placebo (3.48 ± 2.85) groups were not significantly different in the first cycle; however, scores in the treatment group were significantly better in the second (2.56 ± 1.97 vs 3.80 ± 2.77) and third (1.95 ± 1.72 vs 3.95 ± 2.82) cycles. No significant differences were observed between the groups in the nausea and vomiting incidence and the requirement for additional analgesics. Conclusions Zinc sulfate reduces dysmenorrhoea severity with minimal or no adverse effects, especially with more than one cycle of usage. Trial Registration Number: PACTR202105843292338. The trial is publicly available and was registered at www.pactr.org on 25 May 2021.

Serum zinc level might be related to pathogenesis of febrile seizure (FS). The purpose of this study was to evaluate efficacy and safety of oral zinc supplementation on FS recurrence prevention in non-zinc-deficient children. In a randomized clinical study, one hundred 18 to 60 mo old children with normal zinc level with first simple FS were referred to Shahid Sadoughi Hospital, Yazd, Iran from May 2012 to June 2013, were randomly assigned to two groups to receive 2 mg/kg/d zinc sulfate for six consecutive months or placebo as control group and were followed up for 1 y for FS recurrence. 41 girls and 59 boys with mean age of 2.47 ± 1.01 y were evaluated. Race, mean weight, height and body fat were similar in both groups. FS recurrence occurred in 19 children (38%) in the control group [95% confidence interval (CI): 19.45%–53.95%] and in 11 children (22%) in the zinc sulfate (95% CI: 57.47%–89.13%) groups, respectively; and the zinc group had lower FS recurrence (P = 0.03). The mean serum zinc level before intervention was lower in children with FS recurrence (72.43 ± 14.58 μg/dL versus 96.33 ± 12.69 μg/dL, P = 0.04). Gastrointestinal side effects (vomiting in five children, heartburn in two children and abdominal pain in one child) were seen in 16% of the zinc group and vomiting occurred in two children (4%) in control group and frequency of adverse events was similar in the two groups (P = 0.1). Zinc supplementation should be considered as effective and safe in prevention of FS recurrence. •Efficacy of zinc sulfate on febrile seizure recurrence prevention was evaluated.•Febrile seizure recurrence was lower in children who received zinc supplement.•No serious or life-threatening side effects were observed in zinc group.•Children with febrile seizure recurrence had lower serum zinc levels.•Zinc can be used as an effective drug in prevention of febrile seizure recurrence.

In rats, mice, and humans, it is known that zinc deficiency may be related to anemia, and zinc supplementation influences hemoglobin production. Our previous studies indicate that in fish, zinc supplementation stimulates red blood cell (RBC) formation (erythropoiesis). However, it is not clear whether the mechanism of zinc-induced erythropoiesis stimulation in fish also occurs in rats. We induced anemia in rats using phenylhydrazine (PHZ) and injected either saline or ZnSO4 solution. We found that an appropriate amount of zinc stimulated erythropoiesis in the PHZ-induced anemic rats. The effects of ZnSO4 injection were dose-dependent. When the concentration of ZnSO4 was higher than 2.8 mg zinc/kg body weight, the RBC level of the anemic rats increased from 60 ± 7% to 88 ± 10% that of the normal rats in two days. Rat bone marrow cells with or without ZnCl2 supplementation were cultured in suspension in vitro. In the cell culture when the zinc concentration was at 0.3 mM, a 1.6-fold proliferation of nascent immature reticulocytes (new RBCs) was observed after one day. In the rat blood, zinc was combined with serum transferrin to induce erythropoiesis. The stimulation of RBC formation by zinc appears to be common among different animals.

We designed a double-blinded randomized clinical trial of zinc (10 or 20 mg of zinc sulphate for 2–5 month-old or 6–59 month-old children, respectively, during 10 days) vs. placebo in otherwise healthy children aged 2 months to 5 years who presented with acute diarrhoea (i.e. ≥3 stools/day for less than 72 h). Eighty-seven patients (median age 14 months; range 3.1–58.3) were analysed in an intention-to-treat approach. Forty-two patients took zinc and 45 placebo. There was no difference in the duration nor in the frequency of diarrhoea, but only 5 % of the zinc group still had diarrhoea at 120 h of treatment compared to 20 % in the placebo group ( P  = 0.05). Thirty-one patients (13 zinc and 18 placebo) were available for per-protocol analyses. The median (IQR) duration of diarrhoea in zinc-treated patients was 47.5 h (18.3–72) and differed significantly from the placebo group (median 76.3; IQR 52.8–137) ( P  = 0.03). The frequency of diarrhoea was also lower in the zinc group ( P  = 0.02). Conclusion : zinc treatment decreases the frequency and severity of diarrhoea in children aged 2 months to 5 years living in Switzerland. However, the intention-to-treat analysis reveals compliance issues that question the proper duration of treatment and the choice of optimal pharmaceutical formulation. What is known • The effectiveness of zinc in childhood diarrhoea has been demonstrated in developing countries. It helps to decrease the duration and severity of diarrhoea. There is currently no sufficient data to justify its use in developed countries, where there is, theoretically, no zinc deficiency. What is new • We demonstrated the effectiveness of zinc in diarrhoea of children living in a developed country. This confirms the result of two studies (Passariello 2011, and Dalgic 2011) that also reported the positive impact of zinc in diarrhoea of children living in Italy and in Turkey. However, our population is wider in terms of age (2–60 months compared to 3–36 months for Passariello’s study and 1–28 months for Dalgic’s study) and is not limited to a specific aetiology or to a certain degree of severity of the diarrhoea. Furthermore, it’s the first study that uses a placebo for the control group. The main limitation of our study is the differences in the intention-to-treat and the per-protocol analyses that reveal big compliance problems. These could be dealt by changing the dosage form of the zinc formula and/or by diminishing the treatment duration.