1.
Effect of Oral Vitamin D3 Supplementation in Exclusively Breastfed Newborns: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.
Lin, CH, Lin, CY, Sung, YH, Li, ST, Cheng, BW, Weng, SL, Chang, SJ, Lee, HC, Lee, YJ, Ting, WH, et al
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2022;(4):786-793
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Abstract
Exclusively breastfed infants are at a high risk of vitamin D deficiency. Few studies have evaluated the effects of vitamin D supplementation. Hence, we conducted a prospective randomized controlled trial investigating the effects of oral vitamin D3 400 IU/d supplementation in exclusively breastfed newborns. Serum 25-hydroxy-vitamin D (25[OH]D) levels in pregnant women and their newborns were evaluated. Breastfed newborns were randomized to one of two regimens at age 10 days. One group received vitamin D3 supplementation at a dose of 400 IU/d (vD-400 group), whereas the placebo group received a liquid product without vitamin D3. Outcomes were assessed at 4 months of age. A total of 92 pregnant women and their infants were enrolled, and the data of 72 infants (37 in the vD-400 group and 35 in the placebo group) who completed the study at 4 months of age were assessed. The results showed severe vitamin D deficiency in 15.2% of mothers before delivery, while 54.3% had vitamin D deficiency. Moreover, 15.2% of newborns presented with severe vitamin D deficiency at birth, while 52.2% had vitamin D deficiency. Maternal vitamin D levels were significantly correlated with infant vitamin D levels at birth (r = 0.816, p < 0.001). At 4 months of age, weight, head circumference, serum 25(OH)D, phosphorus, and intact parathyroid hormone levels significantly differed between the vD-400 and placebo groups. However, the body length and bone mineral density of the two groups did not differ significantly. Regardless of vitamin D supplementation, participants with severe vitamin D deficiency had significantly higher intact parathyroid hormone levels and lower bone mineral content. In conclusion, among exclusively breastfed infants, oral supplementation with vitamin D3 at a dose of 400 IU/d from age 10 days increased 25(OH)D concentrations at 4 months of age, but it did not affect bone mineralization. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
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Evaluation of the postoperative cognitive dysfunction in elderly patients with general anesthesia.
Chi, YL, Li, ZS, Lin, CS, Wang, Q, Zhou, YK
European review for medical and pharmacological sciences. 2017;(6):1346-1354
Abstract
OBJECTIVE The present study is aimed to study the neuron-specific enolase (NSE) and S100b proteins in the evaluation of postoperative cognitive dysfunction in elderly patients with general anesthesia. PATIENTS AND METHODS A total of 142 aged patients, who were treated with transurethral resection of the prostate (TURP) surgery under general anesthesia with propofol from June 2014 to December 2015, were randomly divided into two groups. The experiment group was given scopolamine butylbromide by intramuscular injection before the operation, while the control group had no preoperative intramuscular injection. The propofol was used for maintenance during the operation. The Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) scales were adopted for testing the patients on preoperative day 1, postoperative day 2 and postoperative day 9. After the surgery, there were 4 cases of postoperative cognitive dysfunction (POCD) patients in experiment group, while 21 cases of POCD patients in control group. While the 142 healthy adult volunteers, who were admitted to physical examination center of our hospital in the corresponding period, were selected as healthy controls. The expression levels of S100b and NSE of patients, as well as healthy controls, were detected by ELISA. RESULTS In POCD patients, serum S100b and NSE levels were evidently higher than those of patients without POCD and healthy control group (p < 0.05). S100b and NSE levels of POCD patients in experiment group were significantly lower than those of control group (p < 0.05). Serum S100b and NSE levels are higher, the longer duration of POCD is, as the correlation coefficient rs = -0.1342, -1.6644, p < 0.05. CONCLUSIONS The expression levels of S100b protein and plasma NSE in the serum of POCD patients increased, which indicated the severity of the disease. The preoperative intramuscular injection of scopolamine butylbromide has important clinical significance for the prevention of POCD.
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Flecainide in Amyotrophic Lateral Sclerosis as a Neuroprotective Strategy (FANS): A Randomized Placebo-Controlled Trial.
Park, SB, Vucic, S, Cheah, BC, Lin, CS, Kirby, A, Mann, KP, Zoing, MC, Winhammar, J, Kiernan, MC
EBioMedicine. 2015;(12):1916-22
Abstract
BACKGROUND Abnormalities in membrane excitability and Na(+) channel function are characteristic of amyotrophic lateral sclerosis (ALS). We aimed to examine the neuroprotective potential, safety and tolerability of the Na(+) channel blocker and membrane stabiliser flecainide in ALS. METHODS A double-blind, placebo-controlled, randomised clinical trial of flecainide (200 mg/day) for 32-weeks with a 12-week lead-in phase was conducted in participants with probable or definite ALS recruited from multiple Australian centres (ANZCT Registry number ACTRN12608000338369). Patients were reviewed by a cardiologist to rule out cardiac contraindications. Participants were randomly assigned (1:1) to flecainide or placebo using stratified permuted blocks by a central pharmacy. The primary outcome measure was the slope of decline of the ALS Functional Rating Scale-revised (ALS FRS-r) during the treatment period. FINDINGS Between March 11, 2008 and July 1, 2010, 67 patients were screened, 54 of whom were randomly assigned to receive flecainide (26 patients) or placebo (28 patients). Four patients in the flecainide group and three patients in the placebo group withdrew from the study. One patient in the flecainide group died during the study, attributed to disease progression. Flecainide was generally well tolerated, with no serious adverse events reported in either group. There was no significant difference in the rate of decline in the primary outcome measure ALS-FRS-r between placebo and flecainide treated patients (Flecainide 0.65 [95% CI 0.49 to 0.98]; Placebo 0.81 [0.49 to 2.12] P = 0.50). However, the rate of decline of the neurophysiological index was significantly reduced in the flecainide group (Flecainide 0.06 [0.01 to 0.11]; Placebo 0.14 [0.09 to 0.19], P = 0.02). Placebo-treated patients demonstrated greater CMAP amplitude reduction during the course of the study in the subset of patients with a reduced baseline CMAP amplitude (Flecainide: - 15 ± 12%; Placebo - 59 ± 12%; P = 0.03). Flecainide-treated patients maintained stabilized peripheral axonal excitability over the study compared to placebo. INTERPRETATION This pilot study indicated that flecainide was safe and potentially biologically effective in ALS. There was evidence that flecainide stabilized peripheral axonal membrane function in ALS. While the study was not powered to detect evidence of benefit of flecainide on ALS-FRS-r decline, further studies may demonstrate clinical efficacy of flecainide in ALS.