scholarly journals Effect of Moringa supplementation in the management of moderate malnutrition in children under 5 receiving ready-to-use supplementary foods in Niger: A randomized clinical trial

2021 ◽  
Vol 8 (3) ◽  
pp. 071-086
Author(s):  
Mahamane Laouali MANZO ◽  
Mahaman Elhadji HALLAROU ◽  
Maimouna DOUDOU HALIDOU ◽  
Daouda ALHOUSSEINI MAIGA ◽  
Paluku BAHWERE ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Moringa Oleifera ◽  
Acute Malnutrition ◽  
Average Weight ◽  
Hepatic Toxicity ◽  
Double Blind ◽  
Nutritional Recovery ◽  
Nutrition Rehabilitation ◽  
The Impact ◽  
Children Under 5

Each year in Niger, more than 40% of children under 5 years suffer from chronic malnutrition and more than 10% from acute malnutrition. The national nutrition rehabilitation protocol encourages the use of local foods. The objective of this work is to analyze the impact of supplementation in Moringa oleifera. We conducted a randomized double-blind clinical trial in 400 children with moderate acute malnutrition (MAM) aged 6 to 59 months admitted to outpatient nutritional recovery centers (CRENAM). The children were divided into two groups; one group received Ready-to-Use Supplemental Foods (RUSF) and dry leaf powder from Moringa oleifera and the other group received RUSF and placebo. We did not find any difference on average weight gain between the two groups or on mid-upper arm circumference and size. The median length of stay in CRENAM was 5 and 4 weeks for Moringa and placebo respectively, with no statistical difference (P=0.522). The cure rate was 82% (2.72) in the Moringa group with a RR of 1.03 (0.94 to 1.13) slightly in favor of Moringa. Renal and hepatic toxicity of Moringa was not observed. From this clinical trial, it could be held that Moringa supplementation, despite the presence of nutritional indices in favor of Moringa, does not have a significant effect on the nutritional recovery of MAM children but that Moringa has no renal or hepatic toxicity. Supplementation in subjects already on dietetic treatment, dose reduced to minimum and duration of supplementation seems to have played a role in this absence of effect of Moringa.

scholarly journals Publisher Correction to: BRAINSTORMING: A study protocol for a randomised double-blind clinical trial to assess the impact of concurrent brain stimulation (tDCS) and working memory training on cognitive performance in Acquired Brain Injury (ABI)

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Sara Assecondi ◽  
Rong Hu ◽  
Gail Eskes ◽  
Michelle Read ◽  
Chris Griffiths ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Working Memory ◽  
Brain Injury ◽  
Cognitive Performance ◽  
Acquired Brain Injury ◽  
Working Memory Training ◽  
Memory Training ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
The Impact

Following publication of the original article [1], the authors flagged that the article had published with the Acknowledgements erroneously excluded from the declarations at the end of the article.

scholarly journals Preventive Effect of Liothyronine on Electroconvulsive Therapy-Induced Memory Deficit in Patients with Major Depressive Disorder: A Double-Blind Controlled Clinical Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Arash Mohagheghi ◽  
Asghar Arfaie ◽  
Shahrokh Amiri ◽  
Masoud Nouri ◽  
Salman Abdi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Electroconvulsive Therapy ◽  
Visual Memory ◽  
Memory Deficit ◽  
Control Group ◽  
Major Depressive ◽  
Double Blind ◽  
The Impact

Introduction and Objective. Despite the effectiveness of electroconvulsive therapy (ECT) in treating major depressive disorder (MDD), its cognitive side effects make it less popular. This study investigated the impact of liothyronine on ECT-induced memory deficit in patients with MDD.Methodology. This is a double-blind clinical trial, in which 60 patients with MDD who were referred for ECT were selected. The diagnosis was based on the criteria of DSM-IV-TR. Patients were divided randomly into two groups to receive either liothyronine (50 mcg every morning) or placebo. After the assessment with Wechsler Memory Scale-Revised (WMS-R) before first session of ECT, posttests were repeated again, two months after the completion of ECT.Findings. By controlling the pretest scores, the mean scores of the experimental group were higher than the control group in delayed recall, verbal memory, visual memory, general memory, and attention/concentration scales (P<0.05).Conclusion. Liothyronine may prevent ECT-induced memory impairment in patients with MDD. This study has been registered in IRCT underIRCT201401122660N2.

Increased risk of acquisition and transmission of ESBL-producing Enterobacteriaceae in malnourished children exposed to amoxicillin

2019 ◽  
Vol 75 (3) ◽  
pp. 709-717 ◽  
Author(s):  
Naouale Maataoui ◽  
Céline Langendorf ◽  
Fatou Berthe ◽  
Jumamurat R Bayjanov ◽  
Willem van Schaik ◽  
...  
Keyword(s):  
Placebo Group ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Double Blind ◽  
Adjusted Risk ◽  
Malnourished Children ◽  
Nutritional Recovery ◽  
Adjusted Risk Ratio ◽  
Increased Risk

Abstract Objectives Routine amoxicillin for children with uncomplicated severe acute malnutrition raises concerns of increasing antibiotic resistance. We performed an ancillary study nested within a double-blind, placebo-controlled trial in Niger testing the role of routine 7 day amoxicillin therapy in nutritional recovery of children 6 to 59 months of age with uncomplicated severe acute malnutrition. Methods We screened 472 children for rectal carriage of ESBL-producing Enterobacteriaceae (ESBL-E) as well as their household siblings under 5 years old, at baseline and Week 1 (W1) and Week 4 (W4) after start of therapy, and characterized strains by WGS. ClinicalTrials.gov: NCT01613547. Results Carriage in index children at baseline was similar in the amoxicillin and the placebo groups (33.8% versus 27.9%, P = 0.17). However, acquisition of ESBL-E in index children at W1 was higher in the amoxicillin group than in the placebo group (53.7% versus 32.2%, adjusted risk ratio = 2.29, P = 0.001). Among 209 index and sibling households possibly exposed to ESBL-E transmission, 16 (7.7%) had paired strains differing by ≤10 SNPs, suggesting a high probability of transmission. This was more frequent in households from the amoxicillin group than from the placebo group [11.5% (12/104) versus 3.8% (4/105), P = 0.04]. Conclusions Among children exposed to amoxicillin, ESBL-E colonization was more frequent and the risk of transmission to siblings higher. Routine amoxicillin should be carefully balanced with the risks associated with ESBL-E colonization.

scholarly journals The humanitarian emergency in Burundi: evaluation of the operational strategy for management of nutritional crisis

2008 ◽  
Vol 11 (7) ◽  
pp. 699-705 ◽  
Author(s):  
Laura Rossi ◽  
Daniel Verna ◽  
Susie L Villeneuve
Keyword(s):  
Disaster Response ◽  
Admission Rate ◽  
Acute Malnutrition ◽  
Severe Malnutrition ◽  
Humanitarian Emergency ◽  
Emergency Situations ◽  
Reduction Of Mortality ◽  
Set Up ◽  
The Impact ◽  
Children Under 5

AbstractObjectiveTo evaluate the impact and appropriateness of programmes for the management and treatment of severe malnutrition in emergency situations.DesignA central unified database was set up with all data and statistics provided by nutritional centres (NC) active in Burundi.SettingThe paper describes the case of Burundi as an example of the response of the humanitarian community to nutritional crisis.SubjectsSince 1999, more than one million (1 054 210) severely malnourished patients were treated in NC established in Burundi.ResultsPeaks of beneficiaries were registered in 2000 and 2001; the admission rate started to decrease in 2002. In 2004, twenty therapeutic feeding centres (TFC) and 224 supplementary feeding centres (SFC) were active for the treatment of 127 420 beneficiaries. Nutritional programmes were present in every province with a coverage rate of 55 %. The most convincing impact of the nutritional programme in Burundi was the reduction of mortality rate in children under 5 years of age; an impact on the prevalence of acute malnutrition could not be demonstrated. Children under 5 years old accounted for 62 % of beneficiaries in TFC and 76 % in SFC. TFC performance indicators fulfilled the minimum standards in disaster response; the performance of SFC was not so optimal with a low recovery rate (69 % v. >80 %) and a high non-respondent rate (16 % v. <5 %). With the combination of coverage and cure rate, the programme met 44 % of the assessed needs in 2004.ConclusionsIn Burundi the stabilisation of security conditions permitted a combination of humanitarian responses ranging from emergency activities to strengthening of community-based initiatives that could correct the coverage and impact limitations.

scholarly journals Acquisition of Resistant Bowel Flora during a Double-Blind Randomized Clinical Trial of Ertapenem versus Piperacillin-Tazobactam Therapy for Intraabdominal Infections

2005 ◽  
Vol 49 (8) ◽  
pp. 3217-3221 ◽  
Author(s):  
Mark J. DiNubile ◽  
Joseph W. Chow ◽  
Vilas Satishchandran ◽  
Adam Polis ◽  
Mary R. Motyl ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Study Drug ◽  
Resistant Bacteria ◽  
Double Blind ◽  
E Coli ◽  
Double Blind Clinical Trial ◽  
Vancomycin Resistant ◽  
The Impact ◽  
Intraabdominal Infections ◽  
Study Therapy

ABSTRACT Bowel colonization with resistant bacteria can develop in patients receiving broad-spectrum antimicrobial therapy. We compared the impact of two antimicrobial regimens often used to treat intraabdominal infections on susceptibility patterns of bowel flora at the end of therapy. In a double-blind clinical trial, adults with complicated intraabdominal infection requiring surgery were randomized to receive piperacillin-tazobactam (3.375 g every 6 h) or ertapenem (1 g once a day) for 4 to 14 days. Rectal swabs were obtained at baseline and at the end of study therapy to determine the acquisition rates of Enterobacteriaceae resistant to the study drug, extended-spectrum β-lactamase (ESBL)-producing Escherichia coli or Klebsiella species, Pseudomonas aeruginosa resistant to imipenem or piperacillin-tazobactam, and vancomycin-resistant Enterococcus faecalis or Enterococcus faecium. Treated patients were assessable for the acquisition of resistant bacteria if appropriate specimens were obtained at both time points. Enterobacteriaceae resistant to the treatment received were acquired during study therapy by 8/122 assessable piperacillin-tazobactam recipients (6.6%) compared to 0/122 assessable ertapenem recipients (P = 0.007). Neither ESBL-producing E. coli or Klebsiella species nor P. aeruginosa resistant to piperacillin-tazobactam was isolated from patients in either treatment group. Imipenem-resistant P. aeruginosa was acquired by two of the ertapenem recipients (1.6%) versus zero of the piperacillin-tazobactam recipients (P = 0.50). Vancomycin-resistant enterococci were acquired during therapy by 8/125 assessable ertapenem recipients (6.4%) versus 2/123 assessable piperacillin-tazobactam recipients (1.6%; P = 0.10). In this study, the acquisition of resistant Enterobacteriaceae occurred significantly more often in patients treated with piperacillin-tazobactam than in those treated with ertapenem.

scholarly journals Impact of vitamin A supplementation in anaemia during pregnancy: a randomized double blind controlled clinical trial

2018 ◽  
Vol 7 (6) ◽  
pp. 2262
Author(s):  
Shakun Singh ◽  
Rachna Chaudhary ◽  
Vandana Dhama ◽  
Anu Singh ◽  
Urmila Karya
Keyword(s):  
Clinical Trial ◽  
Vitamin A ◽  
Pregnant Women ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Vitamin A Supplementation ◽  
Elemental Iron ◽  
Group A ◽  
Group B ◽  
The Impact

Background: To study the impact of Vitamin A supplementation in anaemia during Pregnancy and thus improving maternal and fetal outcome a Randomized double blind controlled clinical trial was conducted in Department of Obstetrics and Gynaecology, L.L.R.M. Medical college Meerut involving 250 pregnant women in late pregnancy 18-28 weeks with haemoglobin levels <11 g% (7-11 g%)..Methods: The study subjects were divided into two groups: Group A (n=125): Received daily supplement containing Iron (60 mg elemental iron) + Folate (500 mcg) + Vitamin A 20,000 IU weekly for a minimum of 12 weeks. Group B (n=125): Received daily supplement containing iron (60 mg elemental iron) + Folate (500 mcg) for a minimum of 12 weeks.Results: Maximum patients were uneducated belonging to low socioeconomic status. The mean haemoglobin values in Group A and Group B increased from 9.674±1.05 and 9.53±1.04 to 12.2±0.89 and 10.82±1.06 respectively after supplementation. Similarily Serum Ferritin levels increased from 15.96±2.94 and 15.70±2.83 to 78.40±17.82 and 58.64±11.93. Mean corpuscular volume, packed cell volume and red blood cell counts also increased significantly. Maximum haemoglobin levels were achieved with both vitamin A and iron supplementation. The proportion of women who became non anaemic was 97.17% in Group A vs 68.69% in Group B.Conclusions: Vitamin A supplementation improves anaemia and also dramatically improves iron stores in anaemic pregnant women.

scholarly journals Auricular Neuromodulation for Mass Vagus Nerve Stimulation: Insights From SOS COVID-19 a Multicentric, Randomized, Controlled, Double-Blind French Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Claire-Marie Rangon ◽  
Régine Barruet ◽  
Abdelmadjid Mazouni ◽  
Chloé Le Cossec ◽  
Sophie Thevenin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vagus Nerve ◽  
Clinical Outcomes ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Treated Patient ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Non Invasive ◽  
The Impact

Importance: An exacerbated inflammatory response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is believed to be one of the major causes of the morbidity and mortality of the coronavirus disease 2019 (COVID-19). Neuromodulation therapy, based on vagus nerve stimulation, was recently hypothesized to control both the SARS-CoV-2 replication and the ensuing inflammation likely through the inhibition of the nuclear factor kappa-light-chain-enhancer of activated B cells pathway and could improve the clinical outcomes as an adjunct treatment. We proposed to test it by the stimulation of the auricular branch of the vagus nerve, i.e., auricular neuromodulation (AN), a non-invasive procedure through the insertion of semipermanent needles on the ears.Objective: The aim of this study was to assess the effect of AN on the clinical outcomes in patients affected by COVID-19.Design, Setting, and Participants: A multicenter, randomized, placebo-controlled, double-blind clinical trial included 31 patients with respiratory failure due to COVID-19 requiring hospitalization. Within 72 h after admission, patients received either AN (n = 14) or sham neuromodulation (SN, n = 15) in addition to the conventional treatments.Main Outcome and Measures: The primary endpoint of the study was the rate of a clinical benefit conferred by AN at Day 14 (D14) as assessed by a 7-point Clinical Progression Scale. The secondary endpoint of the study was the impact of AN on the rate of transfer to the intensive care unit (ICU) and on the survival rate at D14.Results: The AN procedure was well-tolerated without any reported side effects but with no significant improvement for the measures of both primary (p &gt; 0.3) and secondary (p &gt; 0.05) endpoints at the interim analysis. None of the AN-treated patients died but one in the SN group did (81 years). Two AN-treated patients (73 and 79 years, respectively) and one SN-treated patient (59 years) were transferred to ICU. Remarkably, AN-treated patients were older with more representation by males than in the SN arm (i.e., the median age of 75 vs. 65 years, 79% male vs. 47%).Conclusion: The AN procedure, which was used within 72 h after the admission of patients with COVID-19, was safe and could be successfully implemented during the first two waves of COVID-19 in France. Nevertheless, AN did not significantly improve the outcome of the patients in our small preliminary study. It is pertinent to explore further to validate AN as the non-invasive mass vagal stimulation solution for the forthcoming pandemics.Clinical Trial Registration: [https://clinicaltrials.gov/], identifier [NCT04341415].

scholarly journals The Impact of Colchicine on The COVID-19 Patients; A Clinical Trial Study

2020 ◽  
Author(s):  
Farhad Salehzadeh ◽  
Farhad Pourfarzi ◽  
Sobhan Ataei
Keyword(s):  
Clinical Trial ◽  
Medical Treatment ◽  
Open Label ◽  
Post Discharge ◽  
Double Blind ◽  
End Points ◽  
Mortality And Morbidity ◽  
Significant Difference ◽  
Standard Medical Treatment ◽  
The Impact

Abstract Background: Severe acute respiratory syndrome COVID-19 infection has evolved into a global pandemic. This study has been designed to evaluate colchicine anti-inflammatory effect on the symptoms course, duration of hospitalization, morbidity and mortality rate, of COVID-19 patients.Methods: In this prospective, open-label, randomized and double blind clinical trial, 100 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from May 21 to June 20, 2020, to either standard medical treatment (Hydroxychloroquine) or colchicine with standard medical treatment. The study took place in Imam Reza hospital of Ardabil city in Iran, with trial registration ID: 47707 (irct.ir). Colchicine group were received 1 mg tablet of colchicine daily alongside the Hydroxychloroquine for 6 days. Primary end points were (1) Length of hospitalization; (2) symptoms and (3) Co-existed disease. Secondary end points were examined 2 weeks after discharge and included (1) mortality and morbidity; (2) re-admission and (3) symptoms. Results: Overall, 100 patients (59 [59%] female; median age, 56 years) fulfilled the admission criteria and were included and randomized at 2 clinical groups. There was no significant difference between the two groups in terms of age and sex. Two groups were not significantly different in terms of underlying diseases and various clinical and para clinical findings although there were not any different during Post-discharge follow-up except for duration of fever (P<0.05). Comparing two groups showed significantly different only in the duration of hospitalized (P<0.05). Although in colchicine group dyspnea was improved more rapid than the placebo group, but it was not meaningful. Conclusion: Colchicine can be effective in reducing systemic symptoms of COVID-19 by inhibiting inflammatory biomarkers.Current Controlled prospective Trials registration ID that has been approved by ICMJE and WHO ICTRP registry is IRCT20200418047126N1, and the date of registration is 2020-05-14.

scholarly journals What Are the Participants’ Perspectives of Taking Melatonin for the Treatment of Nocturia in Multiple Sclerosis? A Qualitative Study Embedded within a Double-Blind RCT

2018 ◽  
Vol 2018 ◽  
pp. 1-9
Author(s):  
Rafiyah Khan ◽  
Alan Uren ◽  
Luke Canham ◽  
David Cottrell ◽  
Marcus J. Drake ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Psychological Functioning ◽  
Qualitative Interviews ◽  
Negative Effects ◽  
Double Blind ◽  
Trial Treatment ◽  
The Central Nervous System ◽  
Qualitative Exploration ◽  
The Impact

Background. Multiple Sclerosis (MS) is a chronic neurological disorder caused by neurodegeneration within the central nervous system. It results in impaired physical, cognitive, and psychological functioning and can also lead to lower urinary tract symptoms including nocturia. While clinical trials have suggested an association between nocturia and melatonin secretion, to our knowledge, no qualitative research has been conducted on the experience of taking melatonin to treat nocturia in progressive MS within a clinical trial. Methods. 17 semistructured qualitative interviews were conducted as part of a double-blind, randomised, placebo controlled, crossover, clinical trial with consenting adults with MS. Interviews explored participants’ experiences of nocturia associated with MS and their experience of taking melatonin as a trial treatment for nocturia versus a placebo. Data was analysed using a thematic analysis. Results. Themes on the experience of nocturia revealed participants’ understandings of nocturia, the impact it had on their night, and increased daily fatigue. Themes on the intervention showed perceived improvements to nocturia, sleep, and energy and negative effects including lethargy, a lack of significant change, and physical side effects including vivid dreams. Conclusion. This qualitative exploration revealed an association between nocturia and increased levels of fatigue during the day by those with MS. However, perspectives towards the effectiveness of melatonin as a potential treatment varied as both placebo and melatonin were perceived as having very similar effects.

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