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Randomized Controlled Trial Supplement

María Velasco, Teresa Requena, Alberto Delgado-Iribarren, Carmen Peláez, Carlos Guijarro
GOAL: To evaluate the effect of yogurt supplemented with probiotic bacteria on the prevention of antibiotic-associated diarrhea (AAD) in hospitalized patients. BACKGROUND: Diarrhea following antibiotic administration is a frequent clinical problem. The usefulness of probiotics for the prevention of AAD in the hospitalized adult population remains unclear. STUDY: A randomized, double-blind, placebo-controlled clinical trial was conducted in hospitalized patients who started antibiotic treatment...
November 14, 2018: Journal of Clinical Gastroenterology
Kristin Wickens, Christine Barthow, Edwin A Mitchell, Janice Kang, Noleen van Zyl, Gordon Purdie, Thorsten Stanley, Penny Fitzharris, Rinki Murphy, Julian Crane
BACKGROUND: In a two-centre randomized placebo-controlled trial of Lactobacillus rhamnosus HN001 (HN001) (6 × 109 colony-forming units [cfu]) or Bifidobacterium lactis HN019 (HN019) (9 × 109 cfu) taken daily from 35-week gestation to 6 months' post-partum in mothers while breastfeeding and from birth to age 2 years in infants, we showed that HN001 significantly protected against eczema development at 2, 4 and 6 years and atopic sensitization at 6 years. There was no effect of HN019...
November 14, 2018: Pediatric Allergy and Immunology
Siraj Omar Wali, Bahaa Abaalkhail, Faris Alhejaili, S R Pandi-Perumal
PURPOSE: Restless legs syndrome is a movement sleep disorder that may be linked to dopaminergic dysfunction and in which vitamin D may play a role. This 12-week randomized, placebo-controlled trial elucidated the efficacy of vitamin D supplements in decreasing restless legs syndrome symptom severity. METHODS: Thirty-five subjects with restless legs syndrome, diagnosed using the International Restless Legs Syndrome Study Group criteria, were enrolled. The subjects were randomized to orally receive either vitamin D (50,000 IU caplets) or a placebo...
November 14, 2018: Sleep & Breathing, Schlaf & Atmung
Andreas Walther, Jonas Breidenstein, Robert Miller
Importance: Countering depressive disorders is a public health priority. Currently, antidepressants are the first-line treatment, although they show modest effects. In men, testosterone treatment is a controversial alternative or adjunct treatment option. Objectives: To examine the association of testosterone treatment with alleviation of depressive symptoms in men and to clarify moderating effects of testosterone status, depression status, age, treatment duration, and dosage...
November 14, 2018: JAMA Psychiatry
Reza Tabrizi, Omid Reza Tamtaji, Kamran B Lankarani, Naghmeh Mirhosseini, Maryam Akbari, Ehsan Dadgostar, Payam Peymani, Zatollah Asemi
There are several current trials investigating the effect of resveratrol supplementation on biomarkers of inflammation and oxidative stress among patients with metabolic syndrome (MetS); however, their findings are controversial. This systematic review and meta-analysis of randomized controlled trials (RCTs) were conducted to summarize the existing evidence and collectively determine the effects of resveratrol supplementation on biomarkers of inflammation and oxidative stress among patients with MetS and related disorders...
November 14, 2018: Food & Function
Keith P West, Lee S-F Wu, Hasmot Ali, Rolf D W Klemm, Karen Margaret Edmond, Lisa Hurt, Betty Kirkwood, Sam Newton, Caitlin Shannon, Sunita Taneja, Sarmila Mazumder, Kiran Bhatia, Nita Bhandari, Joanne Katz, James M Tielsch, Jean Humphrey, Tina Agoestina, Sajid Bashir Soofi, Shabina Ariff, Zaid Bhatti, Simon Cousens, Zulfiqar A Bhutta, Robert Ntozini, Honorati Masanja, Emily R Smith, Alfa Muhihi, Wafaie Fawzi, Rajiv Bahl, Jose Martines, Sachiyo Yoshida
BACKGROUND: Biannual vitamin A supplementation is a well-established survival tool for preschool children 6 months and older in vitamin A deficient populations but this schedule misses the opportunity to intervene on most young infant deaths. Randomised trials of neonatal vitamin A supplementation (NVAS) in the first few days of life to assess its impact on under 6-month mortality in low/middle-income countries have had varying results. METHODS: Investigators of 11 published randomised placebo-controlled NVAS trials (n=163 567 children) reanalysed their data according to an agreed plan and pooled the primary outcomes of mortality from supplementation through 6 and 12 months of age using random effects models and meta-regression...
November 13, 2018: Archives of Disease in Childhood
Erica L Plummer, Dieter M Bulach, Gerald L Murray, Susan E Jacobs, Sepehr N Tabrizi, Suzanne M Garland
BACKGROUND: The ProPrems trial, a multi-center, double-blind, placebo-controlled randomized trial, previously reported a 54% reduction in necrotizing enterocolitis (NEC) of Bell stage 2 or more from 4.4 to 2.0% in 1099 infants born before 32 completed weeks' gestation and weighing < 1500 g, receiving probiotic supplementation (with Bifidobacterium longum subsp. infantis BB-02, Streptococcus thermophilus TH-4 and Bifidobacterium animalis subsp. lactis BB-12). This sub-study investigated the effect of probiotic supplementation on the gut microbiota in a cohort of very preterm infants in ProPrems...
November 13, 2018: BMC Microbiology
Kalliopi Georgakouli, Ioannis G Fatouros, Apostolos Fragkos, Theofanis Tzatzakis, Chariklia K Deli, Konstantinos Papanikolaou, Yiannis Koutedakis, Athanasios Z Jamurtas
G6PD deficiency renders cells more susceptible to oxidative insults, while antioxidant dietary supplementation could restore redox balance and ameliorate exercise-induced oxidative stress. To examine the effects of alpha-lipoic acid (ALA) supplementation on redox status indices in G6PD deficient individuals, eight male adults with G6PD deficiency (D) participated in this randomized double-blind placebo-controlled crossover trial. Participants were randomly assigned to receive ALA (600 mg/day) or placebo for 4 weeks separated by a 4-week washout period...
November 12, 2018: Antioxidants (Basel, Switzerland)
J Tayama, S Ogawa, N Nakaya, T Sone, T Hamaguchi, A Takeoka, K Hamazaki, H Okamura, J Yajima, M Kobayashi, M Hayashida, S Shirabe
BACKGROUND: This study assessed whether a combined intervention of omega-3 polyunsaturated fatty acids (PUFAs) and psychoeducation better improved mild to moderate depression in workers compared to psychoeducation alone. METHODS: This study was a double-blinded, parallel group, randomized controlled trial that compared the intervention group, receiving omega-3 fatty acids, with a control group, receiving a placebo supplement. Participants receiving omega-3 fatty acids took 15 × 300 mg capsules per day for 12 weeks...
November 6, 2018: Journal of Affective Disorders
Wac Kristine Koekkoek, Vasilianna Panteleon, Arthur Rh van Zanten
Fish oil exerts anti-inflammatory and immunomodulatory properties that may be beneficial for critically ill patients, thus multiple randomized controlled trials and meta-analyses have been performed. However, controversy remains as to whether fish oil-enriched enteral nutrition can improve clinical outcomes in adult critically ill patients in intensive care units (ICUs). The aim of this study was to provide an up-to-date systematic review and meta-analysis of all randomized controlled trials of fish oil-containing enteral nutrition addressing relevant clinical outcomes in critically ill patients...
July 31, 2018: Nutrition
Rebecca Kofod Vinding, Jakob Stokholm, Astrid Sevelsted, Bo L Chawes, Klaus Bønnelykke, Malin Barman, Bo Jacobsson, Hans Bisgaard
Background: Randomized trials have reported that supplementation with n-3 long-chain polyunsaturated fatty acids (LCPUFAs) in pregnancy can prolong pregnancy and thereby increase birth weight. Objective: We aimed to examine the relations of n-3 LCPUFA supplementation in pregnancy with duration of pregnancy, birth weight, and size for gestational age (GA). Methods: This was a double-blind randomized controlled trial conducted in 736 pregnant women and their offspring, from the Copenhagen Prospective Studies on Asthma in Childhood2010cohort...
November 9, 2018: Journal of Nutrition
Marzieh Bakhshayeshkaram, Kamran B Lankarani, Naghmeh Mirhosseini, Reza Tabrizi, Maryam Akbari, Mohammad Hossein Dabbaghmanesh, Zatollah Asemi
BACKGROUND: This systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to determine the effects of coenzyme Q10 (CoQ10) supplementation on metabolic profiles of patients diagnosed with chronic kidney disease (CKD). METHODS: Two independent reviewers systematically searched online databases including PubMed, Cochrane Library, and Web of Science databases, Scopus, EMBASE until July 2018 to identify eligible clinical trials. The heterogeneity across included trials was assessed using Cochran's Q test and I-square (I2) statistic...
November 11, 2018: Current Pharmaceutical Design
Gil Yosipovitch, Peter Foley, Caitriona Ryan, Jennifer C Cather, Kim A Meeuwis, Russel Burge, Alison Potts Bleakman, Chen-Yen Lin, William Malatestinic, Alice Gottlieb
INTRODUCTION: Genital psoriasis (GenPs) is common and distressing for patients, but is often not discussed with physicians, and no previous clinical trials have assessed the effects of biologics specifically on GenPs and its associated symptoms. AIM: To report results for novel patient-reported outcomes (PROs) for the assessment of symptoms and the sexual impact of GenPs before and after treatment in the IXORA-Q study. METHODS: IXORA-Q (NCT02718898) was a phase III, randomized, double-blind, placebo-controlled study of ixekizumab (80 mg/2 weeks after 160-mg initial dose) vs placebo for GenPs...
November 2018: Journal of Sexual Medicine
JoAnn E Manson, Nancy R Cook, I-Min Lee, William Christen, Shari S Bassuk, Samia Mora, Heike Gibson, Christine M Albert, David Gordon, Trisha Copeland, Denise D'Agostino, Georgina Friedenberg, Claire Ridge, Vadim Bubes, Edward L Giovannucci, Walter C Willett, Julie E Buring
BACKGROUND: Higher intake of marine n-3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several observational studies. Whether supplementation with n-3 fatty acids has such effects in general populations at usual risk for these end points is unclear. METHODS: We conducted a randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D3 (at a dose of 2000 IU per day) and marine n-3 fatty acids (at a dose of 1 g per day) in the primary prevention of cardiovascular disease and cancer among men 50 years of age or older and women 55 years of age or older in the United States...
November 10, 2018: New England Journal of Medicine
JoAnn E Manson, Nancy R Cook, I-Min Lee, William Christen, Shari S Bassuk, Samia Mora, Heike Gibson, David Gordon, Trisha Copeland, Denise D'Agostino, Georgina Friedenberg, Claire Ridge, Vadim Bubes, Edward L Giovannucci, Walter C Willett, Julie E Buring
BACKGROUND: It is unclear whether supplementation with vitamin D reduces the risk of cancer or cardiovascular disease, and data from randomized trials are limited. METHODS: We conducted a nationwide, randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D3 (cholecalciferol) at a dose of 2000 IU per day and marine n-3 (also called omega-3) fatty acids at a dose of 1 g per day for the prevention of cancer and cardiovascular disease among men 50 years of age or older and women 55 years of age or older in the United States...
November 10, 2018: New England Journal of Medicine
Fereshteh Bahmani, Fatemeh Rahimi Galougahi, Zahra Vahedpoor, Mehri Jamilian, Samaneh Mahmoodi, Raheleh Baghban, Tayebeh Bagherian, Maryam Zarezade Mehrizi, Zatollah Asemi
BACKGROUND: Data on the effects of folic acid supplementation on clinical symptoms and metabolic profiles of patients with endometrial hyperplasia (EH) are limited. This investigation was performed to evaluate the effects of folic acid supplementation on clinical symptoms and metabolic status of patients with EH. METHODS: This randomized, double-blind, placebo-controlled trial was conducted among 60 women diagnosed with EH. Diagnosis of EH was made based on biopsy results...
October 1, 2018: Archives of Iranian Medicine
Yun-Jing Zhang, Shi-Liang Han, Xi-Feng Sun, Shu-Xiang Wang, Hong-Yun Wang, Xiao Liu, Li Chen, Ling Xia
BACKGROUND: This study was designed to evaluate the efficiency and tolerability of empagliflozin (EMPA) as monotherapy or add-on to existing therapy in patients with type 2 diabetes mellitus (T2DM). METHODS: Randomized controlled trials (RCTs) comparing efficacy and safety of EMPA vs placebo or EMPA plus other antidiabetes drugs vs placebo plus other oral antidiabetes drugs (OADs) in T2DM were recruited from electronic database Pubmed, Web of Knowledge, and Cochrane Central Register of Controlled Trials (CENTRAL), supplemented by a hand search of the reference lists of selected articles...
October 2018: Medicine (Baltimore)
Akkarach Bumrungpert, Promluck Somboonpanyakul, Patcharanee Pavadhgul, Siriporn Thaninthranon
BACKGROUND: Exclusive breastfeeding is the best way to accomplish optimal growth and health in infants. Low milk volume is a major problem that leads to nonexclusive breastfeeding. OBJECTIVE: This study aimed to examine the effects of mixed herbal supplementation, including fenugreek, ginger, and turmeric on human milk volume and nutrient content. METHODS: The study design was a randomized double-blind controlled trial. Fifty exclusively breastfeeding mothers were randomly divided into two groups...
November 9, 2018: Breastfeeding Medicine: the Official Journal of the Academy of Breastfeeding Medicine
Rashami Awasthi, Enrico M Minnella, Vanessa Ferreira, Agnihotram V Ramanakumar, Celena Scheede-Bergdahl, Francesco Carli
BACKGROUND: Exercise training is a component of the pre-habilitation program. While in one previous study the training was home-based, in a subsequent investigation it was supervised in hospital. The hypothesis of this secondary analysis of the two studies was to determine whether supervised exercise further accelerates the return to baseline walking ability. METHODS: Data from two consecutive randomized control trials (RCT) comparing pre-habilitation to the rehabilitation of cancer patients scheduled for colorectal surgery were pooled for analysis...
November 8, 2018: Acta Anaesthesiologica Scandinavica
Hamid Reza Talari, Somayyeh Poladchang, Yaser Hamidian, Mansooreh Samimi, Hamid Reza Gilasi, Faraneh Afshar Ebrahimi, Zatollah Asemi
Objectives: We sought to evaluate the effects of omega-3 and vitamin E co-supplementation on carotid intima-media thickness (CIMT) and inflammatory factors in patients with polycystic ovary syndrome (PCOS). Methods: This randomized, double-blind, placebo-controlled trial was done among 60 women with PCOS. Participants were randomly assigned into two groups (n = 30 each group) and assigned to take either 1000 mg omega-3 plus 400 IU vitamin E supplements or a placebo for 12 weeks...
November 2018: Oman Medical Journal
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