scholarly journals Multi-Micronutrient Fortified Rice Improved Serum Zinc and Folate Concentrations of Cambodian School Children. A Double-Blinded Cluster-Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2843
Author(s):  
Khov Kuong ◽  
Pety Tor ◽  
Marlene Perignon ◽  
Marion Fiorentino ◽  
Chhoun Chamnan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Serum Zinc ◽  
Vulnerable Groups ◽  
Serum Folate ◽  
Micronutrient Deficiencies ◽  
Double Blind ◽  
Micronutrient Status ◽  
Zinc Concentrations ◽  
Cluster Randomized ◽  
The Impact

Background: Within Cambodia, micronutrient deficiencies continue to be prevalent in vulnerable groups, such as women and children. Fortification of staple foods such as rice could be a promising strategy for Cambodia to improve micronutrient status. Objective: Our objective was to investigate the impact of multiple-micronutrient fortified rice (MMFR), distributed through a World Food Program school-meals program (WFP-SMP) on serum zinc concentrations and folate status in a double-blind, cluster-randomized, placebo-controlled trial. Methods: Sixteen schools were randomly assigned to receive one of three different types of extruded-fortified rice (UltraRice Original (URO), UltraRice New (URN), or NutriRice) or unfortified rice (placebo) six days a week for six months. A total of 1950 schoolchildren (6–16 years old) participated in the study. Serum zinc (all groups) and folate (only in NutriRice and placebo group) concentrations were assessed from morning non-fasting antecubital blood samples and were measured at three time points (baseline and after three and six months). Results: After six months of intervention, serum zinc concentrations were significantly increased in all fortified rice group compared to placebo and baseline (0.98, 0.85 and 1.40 µmol/L for URO, URN and NutriRice, respectively) (interaction effect: p < 0.001 for all). Children in the intervention groups had a risk of zinc deficiencies of around one third (0.35, 039, and 0.28 for URO, URN, and NutriRice, respectively) compared to the placebo (p < 0.001 for all). The children receiving NutriRice had higher serum folate concentrations at endline compared to children receiving normal rice (+2.25 ng/mL, p = 0.007). Conclusions: This study showed that the high prevalence of zinc and folate deficiency in Cambodia can be improved through the provision of MMFR. As rice is the staple diet for Cambodia, MMFR should be considered to be included in the school meal program and possibilities should be explored to introduce MMFR to the general population.

scholarly journals Multi-Micronutrient–Fortified Biscuits Decreased Prevalence of Anemia and Improved Micronutrient Status and Effectiveness of Deworming in Rural Vietnamese School Children

2009 ◽  
Vol 139 (5) ◽  
pp. 1013-1021 ◽  
Author(s):  
Tran Thuy Nga ◽  
Pattanee Winichagoon ◽  
Marjoleine A. Dijkhuizen ◽  
Nguyen Cong Khan ◽  
Emorn Wasantwisut ◽  
...  
Keyword(s):  
School Children ◽  
Controlled Trial ◽  
Urinary Iodine ◽  
Cost Effective ◽  
Micronutrient Deficiencies ◽  
Parasitic Infestation ◽  
Double Blind ◽  
School Based ◽  
Micronutrient Status ◽  
Micronutrient Fortification

Abstract Concurrent micronutrient deficiencies are prevalent among Vietnamese school children. A school-based program providing food fortified with multiple micronutrients could be a cost-effective and sustainable strategy to improve health and cognitive function of school children. However, the efficacy of such an intervention may be compromised by the high prevalence of parasitic infestation. To evaluate the efficacy of school-based intervention using multi-micronutrient–fortified biscuits with or without deworming on anemia and micronutrient status in Vietnamese schoolchildren, a randomized, double-blind, placebo-controlled trial was conducted among 510 primary schoolchildren, aged 6–8 y, in rural Vietnam. Albendazole (Alb) (400 mg) or placebo was given at baseline. Nonfortified or multi-micronutrient–fortified biscuits including iron (6 mg), zinc (5.6 mg), iodine (35 μg), and vitamin A (300 μg retinol equivalents) were given 5 d/wk for 4 mo. Multi-micronutrient fortification significantly improved the concentrations of hemoglobin (+1.87 g/L; 95% CI: 0.78, 2.96), plasma ferritin (+7.5 μg/L; 95% CI: 2.8, 12.6), body iron (+0.56 mg/kg body weight; 95% CI: 0.29, 0.84), plasma zinc (+0.61 μmol/L; 95% CI: 0.26, 0.95), plasma retinol (+0.041 μmol/L; 95% CI: 0.001, 0.08), and urinary iodine (+22.49 μmol/L; 95% CI: 7.68, 37.31). Fortification reduced the risk of anemia and deficiencies of zinc and iodine by &gt;40%. Parasitic infestation did not affect fortification efficacy, whereas fortification significantly enhanced deworming efficacy, with the lowest reinfection rates in children receiving both micronutrients and Alb. Multi-micronutrient fortification of biscuits is an effective strategy to improve the micronutrient status of Vietnamese schoolchildren and enhances effectiveness of deworming.

scholarly journals Assessing the Impact of a Vi-polysaccharide Conjugate Vaccine in Preventing Typhoid Infection Among Bangladeshi Children: A Protocol for a Phase IIIb Trial

2019 ◽  
Vol 68 (Supplement_2) ◽  
pp. S74-S82 ◽  
Author(s):  
Katherine Theiss-Nyland ◽  
Firdausi Qadri ◽  
Rachel Colin-Jones ◽  
K Zaman ◽  
Farhana Khanam ◽  
...  
Keyword(s):  
Typhoid Fever ◽  
Conjugate Vaccine ◽  
Controlled Trial ◽  
Incidence Rates ◽  
World Health ◽  
Ethical Review ◽  
Research Review ◽  
Double Blind ◽  
Cluster Randomized ◽  
The Impact

AbstractBackgroundTyphoid fever illnesses are responsible for more than 100 000 deaths worldwide each year. In Bangladesh, typhoid fever is endemic, with incidence rates between 292–395 per 100 000 people annually. While considerable effort has been made to improve access to clean water and sanitation services in the country, there is still a significant annual typhoid burden, which particularly affects children. A typhoid conjugate vaccine (Vi-TCV) was recently prequalified by the World Health Organization and recommended for use, and offers the potential to greatly reduce the typhoid burden in Bangladesh.MethodsThis study is a double-blind, cluster-randomized, controlled trial of Vi-TCV in a geographically defined area in Dhaka, Bangladesh. At least 32 500 children from 9 months to &lt;16 years of age will be vaccinated and followed for 2 years to assess the effectiveness and safety of Vi-TCV in a real-world setting. All cluster residents will also be followed to measure the indirect effect of Vi-TCV in this community.Ethics and DisseminationThis protocol has been approved by the International Centre for Diarrhoeal Disease Research, Bangladesh; a University of Oxford research review; and both ethical review committees. Informed written consent and assent will be obtained before enrollment. Vi-TCV has been shown to be safe and effective in previous, smaller-scale studies. The results of this study will be shared through a series of peer-reviewed journal articles. The findings will also be disseminated to the local government, stakeholders within the community, and the population within which the study was conducted.ConclusionsThis trial is the largest and only cluster-randomized control trial of Vi-TCV ever conducted, and will describe the effectiveness of Vi-TCV in an endemic population. The results of this trial may provide important evidence to support the introduction of TCVs in countries with a high burden of typhoid.Clinical Trials RegistrationISRCTN11643110.

scholarly journals Reduced exposure to malaria vectors following indoor residual spraying of pirimiphos-methyl in a high-burden district of rural Mozambique with high ownership of long-lasting insecticidal nets: entomological surveillance results from a cluster-randomized trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Joseph M. Wagman ◽  
Kenyssony Varela ◽  
Rose Zulliger ◽  
Abuchahama Saifodine ◽  
Rodaly Muthoni ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Indoor Residual Spraying ◽  
Malaria Vectors ◽  
Light Traps ◽  
High Burden ◽  
Randomized Controlled ◽  
Pirimiphos Methyl ◽  
Cluster Randomized ◽  
The Impact ◽  
Long Lasting Insecticidal Nets

Abstract Background The need to develop new products and novel approaches for malaria vector control is recognized as a global health priority. One approach to meeting this need has been the development of new products for indoor residual spraying (IRS) with novel active ingredients for public health. While initial results showing the impact of several of these next-generation IRS products have been encouraging, questions remain about how to best deploy them for maximum impact. To help address these questions, a 2-year cluster-randomized controlled trial to measure the impact of IRS with a microencapsulated formulation of pirimiphos-methyl (PM) in an area with high ownership of long-lasting insecticidal nets (LLINs) was conducted in a high-transmission district of central Mozambique with pyrethroid resistant vectors. Presented here are the results of the vector surveillance component of the trial. Methods The 2 year, two-armed trial was conducted in Mopeia District, Zambezia Province, Mozambique. In ten sentinel villages, five that received IRS with PM in October–November 2016 and again in October–November 2017 and five that received no IRS, indoor light trap collections and paired indoor-outdoor human landing collections catches (HLCs) were conducted monthly from September 2016 through October 2018. A universal coverage campaign in June 2017, just prior to the second spray round, distributed 131,540 standard alpha-cypermethrin LLINs across all study villages and increased overall net usage rates in children under 5 years old to over 90%. Results The primary malaria vector during the trial was Anopheles funestus sensu lato (s.l.), and standard World Health Organization (WHO) tube tests with this population indicated variable but increasing resistance to pyrethroids (including alpha-cypermethrin, from > 85% mortality in 2017 to 7% mortality in 2018) and uniform susceptibility to PM (100% mortality in both years). Over the entire duration of the study, IRS reduced An. funestus s.l. densities by 48% (CI95 33–59%; p < 0.001) in indoor light traps and by 74% (CI95 38–90%; p = 0.010) during indoor and outdoor HLC, though in each study year reductions in vector density were consistently greatest in those months immediately following the IRS campaigns and waned over time. Overall there was no strong preference for An. funestus to feed indoors or outdoors, and these biting behaviours did not differ significantly across study arms: observed indoor-outdoor biting ratios were 1.10 (CI95 1.00–1.21) in no-IRS villages and 0.88 (CI95 0.67–1.15) in IRS villages. The impact of IRS was consistent in reducing HLC exposures both indoors (75% reduction: CI95 47–88%; p = 0. < 0.001) and outdoors (68% reduction: CI95 22–87%; p = 0.012). While substantially fewer Anopheles gambiae s.l. were collected during the study, trends show a similar impact of IRS on this key vector group as well, with a 33% (CI95 7–53%; p = 0.019) reduction in mosquitoes collected in light traps and a non-statistically significant 39% reduction (p = 0.249) in HLC landing rates. Conclusion IRS with PM used in addition to pyrethroid-only LLINs substantially reduced human exposures to malaria vectors during both years of the cluster-randomized controlled trial in Mopeia—a high-burden district where the primary vector, An. funestus s.l., was equally likely to feed indoors or outdoors and demonstrated increasing resistance to pyrethroids. Findings suggest that IRS with PM can provide effective vector control, including in some settings where pyrethroid-only ITNs are widely used. Trial registrationclinicaltrials.gov, NCT02910934. Registered 22 September 2016, https://www.clinicaltrials.gov/ct2/show/NCT02910934.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anca Vasiliu ◽  
Sabrina Eymard-Duvernay ◽  
Boris Tchounga ◽  
Daniel Atwine ◽  
Elisabete de Carvalho ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Standard Of Care ◽  
Preventive Therapy ◽  
Community Based ◽  
Randomized Controlled ◽  
Eligible Child ◽  
Contact Investigation ◽  
Cluster Randomized ◽  
The Impact ◽  
Index Cases

Abstract Background There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings. Methods/design This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5–14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm. Discussion This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings. Trial registration ClinicalTrials.gov NCT03832023. Registered on 6 February 2019

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

scholarly journals Exploring alternative insecticide delivery options in a “Lethal House Lure” for malaria vector control

2021 ◽  
Author(s):  
Welbeck A. Oumbouke ◽  
Antoine M.G. Barreaux ◽  
Innocent T. Zran ◽  
Alphonsine A. Koffi ◽  
Yao N’Guessan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Residual Activity ◽  
Alternative Methods ◽  
Malaria Vector Control ◽  
Rapid Decline ◽  
Mosquito Mortality ◽  
Delivery Options ◽  
Control Technologies ◽  
Cluster Randomized ◽  
The Impact

Abstract The In2Care® EaveTube is a house modification designed to block and kill malaria mosquitoes using an electrostatic netting treated with insecticide powder. A previous study demonstrated prolonged duration of effective action of insecticide-treated electrostatic netting in a semi-field setting. As part of a cluster randomized controlled trial (CRT) of the EaveTube intervention in Cote d’Ivoire, we investigated the residual efficacy of a pyrethroid insecticide deployed in Eave Tubes under village condition of use. We also explored the scope of using existing malaria control technologies including LLINs and IRS as alternative methods to deliver insecticides in the lethal house lure. The efficacy of beta-cyfluthrin was evaluated using the “eave tube bioassay” and was found to be relatively short-lived in the field during the CRT, with mortality of pyrethroid resistant Anopheles gambiae mosquitoes declining below 80% after 4 months. The impact (mosquito mortality) of PVC tubes coated with pirimiphos methyl was similar to that of beta-cyfluthrin treated insert (66.8 vs 62.8%) in release-recapture experiments in experimental huts. Efficacy was significantly lower with all the LLINs tested; however, the roof of PermaNet 3.0 induced significantly higher mosquito mortality (50.4%) compared to Olyset Plus (25.9%) and Interceptor G2 (21.6%) LLINs. The new delivery methods showed a rapid decline in efficacy over time with mortality decreasing below 50% within 2 months in residual activity bioassays. None of the current products appeared superior to the powder treatments but as with the powders, further research and development on formulations and doses are required.

scholarly journals Seeing is believing: the impact of body-worn cameras on court outcomes, a cluster-randomized controlled trial in Miami Beach

2021 ◽  
Author(s):  
Kevin Petersen ◽  
Alejandro Mouro ◽  
Donald Papy ◽  
Noel Castillo ◽  
Barak Ariel
Keyword(s):  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Police Officers ◽  
Negative Binomial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Early Results ◽  
Cluster Randomized ◽  
The Impact

Abstract Objectives To assess the effects of BWCs on prosecutorial and court-related charge outcomes across multiple crime types, including domestic violence charges, crimes committed against police officers, and drug/alcohol charges. Methods A cluster-randomized controlled trial with 22 spatiotemporal police units assigned to BWCs and 17 assigned to control conditions. Data from the State Attorney’s Office were used to track convictions, adjudication withheld dispositions, and declined prosecutions for both experimental and control charges. A series of multilevel logistic and negative binomial regression models were used to estimate the effect of BWC footage on charge outcomes. Outcomes BWCs led to a significantly higher proportion of crimes against police officers resulting in convictions or adjudication withheld outcomes, and a significantly higher proportion of domestic violence charges resulting in convictions alone, compared to control charges. However, after the clustering effect was taken into account, only the effect of BWCs on crimes against police officers remained statistically significant. Conclusion These early results suggest that BWCs have significant evidentiary value that varies by crime type. BWCs may be best suited to capture evidence of crimes committed against police officers and potentially in domestic violence offenses as well.

Sign in / Sign up

Export Citation Format

Share Document