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Malnutrition - ClinicalTrials.gov

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Last Updated: 25 September 2022

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Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:

This pilot study is the first in a controlled trial designed to determine the effects of adjunctive azithromycin therapy in children aged 6-59 months in conjunction with standard outpatient care for uncomplicated acute malnutrition in children aged 6-59 months. Upon admission to the program, children attending nutrition services in Burkina Faso will be randomized to either a single dose of oral azithromycin or a 7-day course of amoxicillin.

Source link: https://clinicaltrials.gov/ct2/show/NCT03568643


Simplified Combined Protocol for the Identification and Treatment of Acute Malnutrition in Venezuela

The aim of the research is to document the safety and effectiveness of Venezuelan simplified treatment regimen for Acute malnutrition, reduced frequency of follow-up visits, single product use, and optimized daily RUTF dose. According to the definition case study, which will be published in the Implementation Guidance: Prevention, Early Detection and Treatment of Wasting in Children With Uncomplicated Acute Malnutrition is the subject of a single arm cohort included in therapy, according to the United Nations Children's Fund and World/Health Organization's Context of Coronavirus Disease. As cost per child accounted for and cost per child recovered, total costs will be estimated and presented. The study will be carried out in 19 Community Health Centers, which were ostensibly chosen based on their acute malnutrition prevalence and operational constraints.

Source link: https://clinicaltrials.gov/ct2/show/NCT05543759


Management of Severe Acute Malnutrition in Children With Sickle Cell Disease Greater Than 5 Years of Age Living in Northern Nigeria

This feasibility study is intended to determine the appropriate treatment of severe hunger in children with sickle cell disease older than 5 years of age. About 92% of the cohort in northern N. . . . ia who had severe hunger was below the 5th percentile for children with SCD living in the United States, Canada, or Europe. According to these results, older children with SCD living in northern N. . . . ia are undernourished relative to children living in high-resource settings. Moderate fixed-dose hydroxyurea in children with severe hunger in northern N. . . . ia shows that moderate fixed-dose hydroxyurea raises BMI in children with severe hunger. In preparation for a single phase III trial to determine if a nutritional supplement and moderately fixed-dose hydroxyurea therapy is superior to a nutritional supplement alone, the investigators will randomly assign 100 children aged 5 to 12 years old with SCA and severe uncomplicated hunger to each of the two arms. The investigators will screen and treat up to 100 malnourished non-SCD siblings of the trial participants to reduce the risk of sharing inadequate food sources in a poor family and determine the specificity of SCD in children with SCD in northern N. . . . ia.

Source link: https://clinicaltrials.gov/ct2/show/NCT03634488


Evaluation of Two Optimizing and Simplifying Strategies on Acute Malnutrition Treatment in Children Aged 6 to 59 Months in Mirriah District, Zinder, Niger

The predicted recovery rate for the secondary priority objective n'u00b01 is 82%, and for the secondary priority goal n'u00b02 is 74% with a statistical power of 80%. 568 participants to achieve the main goal are required to fulfill the main objective; 295 participants with acute hunger to meet the secondary target nu00b01. During the outpatient follow-up or at home visits, the trial nurses will complete a paper form. Data entry agents under the direction of a data manager using RedCAP software will record data. According to the Good Clinical Practices' recommendations, data monitoring will be carried out every week at each site by clinical trial monitors under the responsibility of the research activities manager's responsibility. The occurrence of the primary endpoint will be compared between the OptiMA and ComPAS' plans to the standard protocol. The occurrence of the primary secondary endpoint for children randomly randomized in the acute malnourished stratum and for children admitted with a MUAC 115mm will be compared between the OptiMA and ComPAS plans to the standard protocol. If the primary and main secondary studies report non-inferiority in both ITT and PP, the OptiMA and ComPAS' policies will be deemed non-inferior to the standard strategy. Missing data can be vital information if the child is absent at the last visit, as well as anthropometric results.

Source link: https://clinicaltrials.gov/ct2/show/NCT04698070


A Cross-Sectional Study to Estimate the Influence of Malnutrition, Diabetes Mellitus and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population

Mycobacterium tuberculosis is affecting nearly 2 billion people worldwide, with 90 percent of people showing latent infection. As seen in LTBI, the administration of TB requires clearly defined helper T cell 1 responses and, to a lesser extent, Th17 responses, which both play important roles in the induction and maintenance of protective immune responses in mouse models of TB infection and disease prevention. M. tuberculosis is trapped in localized granulomas during latency. HIV is one of the many risk factors that are suspected of promoting active TB, according to research and reports. However, other risk factors may play a larger role in active TB pathogenesis in low-HIV-endemic countries such as India. Individuals with these comorbidities or coinfections may be at a greater risk of developing active TB than those with healthy LTBI counterparts who do not have these comorbidities.

Source link: https://clinicaltrials.gov/ct2/show/NCT04526613


Community-based Management of Acute Malnutrition (CMAM) in Bangladesh: Effectiveness Trial of Locally Developed Ready-to-use Therapeutic Food in the Treatment of Severe Acute Malnutrition in Rohingya Camps in Cox's Bazar

WHO and UNICEF have recommended that children with severe acute hunger in the world without complications in the community, responding to the global burden of childhood acute hunger, including children under the age of childhood acute malnutrition. Nutritional Management was designed by icddr,b to support the community's ongoing SAM management of uncomplicated SAM. If the results confirm that the NMs are safe, either one or both varieties can be used for children with SAM in emergency situations where food insecurity is high. We therefore want to investigate maternal/caregiver attitudes, knowledge, practices, and barriers toward community-based health care management among the FDMN population. In FDMN Forcibly Displaced Myanmar National camps suffering from SAM, the Ministry of Health and Family Welfare of Bangladesh has approved the trial of the local therapeutic foods, Sharnali-1 and Sharnali-2, developed by icddr. b among children under the age of five. Objectives: To determine the success of two local NMs in treating 6-59 months old children with SAM in the community in an emergency situation. Methods: In Cox's Bazar district, we will carry out the Bangladeshi NMs' efficacy trial in the FDMN Camps. Through 90 days of intervention, the primary outcome variable of the effectiveness trial is to determine the percentage of children graduating from SAM to non-acute malnutrition status by 90 days of intervention. There will be 450 children with SAM in two arms as a result of the effectiveness trial.

Source link: https://clinicaltrials.gov/ct2/show/NCT05520879


Serum Levels of Interleukins 6 and 8 in Malnourished Children With Acute Diarrhea

Acute gastroenteritis is a common health condition among children around the world, with elevated morbidity, mortality, and economic burden. Activation diarrhea, acute watery diarrhea, persistent diarrhea, and diarrhea with extreme hunger are all common conditions, according to the WHO. In both high and LMICs, acute watery diarrhea is the most common group. Symptoms of acute watery diarrhea in children are caused by viral infections, especially viruses and parasites, account for the majority of cases. Some studies looked at the role of IL-6 and IL-8 as biomarkers for acute diarrhea in children. The results showed significant serum levels of IL-6 and IL-8 in children with acute GE compared to healthy controls. Severe acute malnutrition is a serious form of hunger that results from inadequate or poor quality dietary intakes. One of the most common causes of decreased immune function in children is hunger. According to In vitro studies, malnourished children's peripheral blood mononuclear cells had reduced ability to produce cytokines, including IL-1, IL-6, IL-8, and tumor necrosis factor alpha. SAM children had significantly lower IL-6 and IL-8 levels relative to healthy controls [8]. To the best of our knowledge, there have been no previous studies on the prevalence of IL-6 and IL-8 in children with SAM and acute diarrhea in children with SAM and acute diarrhea. The aim of this study is to determine interleukins 6 and 8 serum levels in malnourished children with acute diarrhea.

Source link: https://clinicaltrials.gov/ct2/show/NCT05183789


Evaluation of Glycemic Control by Flash Monitoring of Glucose (MFG) in Malnourished Patients With Type 2 Diabetes and Oral Supplements: Standard Formula vs Specific Formula for Diabetes

There is no evidence for selecting a specific tablet for diabetes or a generic supplement for diabetes in people with malnutrition and diabetes who require oral supplementation. There are no studies evaluating flash glucose monitoring in people with DM2 with supplements, nor studies comparing diabetes-specific formulas with standard formulas to standard formulas. The examinations will be administered by a standard supplement for two weeks, upgrade to the MFG system, indicating that the scans were conducted at start-up, at the time and two hours after taking the oral supplement at home, because it does not happen anymore 8 hours without scanning to avoid missing details. Following 14 days participants will arrive for MFG data download and analysis of acute response after taking the supplement in the presence of healthcare workers, investigators will upgrade the sensor and nutritional supplement to a specific diabetes formula.

Source link: https://clinicaltrials.gov/ct2/show/NCT05443204

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions