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Malnutrition clinical trials

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NCT ID: NCT06010719 Not yet recruiting - Malnutrition, Child Clinical Trials

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

AMOUR
Start date: August 2024
Phase: Phase 4
Study type: Interventional

Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, the investigators demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of children with uncomplicated SAM in our study area, and showed no significant difference between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, the investigators propose an individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences in weight gain, nutritional recovery, and the gut microbiome. The results of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to changes in guidelines for treatment.

NCT ID: NCT05994742 Not yet recruiting - HIV Clinical Trials

An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM

Co-SAM
Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

Malnutrition underlies 45% of child deaths, and has far-reaching educational, economic and health consequences. Severe acute malnutrition (SAM) affects 17 million children globally and is the most life-threatening form of malnutrition. Community-based management of acute malnutrition using ready-to-use therapeutic food (RUTF) has transformed outcomes for children with uncomplicated SAM, but those presenting with poor appetite or medical complications (categorised as having 'complicated' SAM) require hospitalisation. Data show that pneumonia, diarrhoea and malaria are leading causes of death in children with complicated SAM after discharge from hospital. High risk of infectious deaths suggests that sustained antimicrobial interventions may reduce mortality following discharge from hospital. Furthermore, children with complicated SAM respond less well to nutritional rehabilitation, and oftentimes are discharged to a home environment characterised by poverty and multiple caregiver vulnerabilities including depression, low decision making autonomy, lack of social support, gender-restricted family relations, and competing demands on scarce resources. Caregivers have to navigate diverse challenges that impede engagement with clinical care after discharge from hospital. The objective is to address the biological and social determinants of multimorbidity in children with complicated SAM by developing multimodal packages of interventions and testing them in a 5-arm adaptive randomized controlled clinical trial, with death/hospitalization or failed nutritional recovery as the primary outcome.

NCT ID: NCT05950373 Not yet recruiting - Malnutrition Clinical Trials

Educational Intervention for Better Nutrition to Preserve Functionality - Design of a Randomised Clinical Trial

Start date: January 1, 2025
Phase: N/A
Study type: Interventional

This project explores whether access to a digital education video can improve the nutritional situation of home-living older adults after being discharged from the hospital.

NCT ID: NCT05944744 Not yet recruiting - Malnutrition Clinical Trials

The Role of Cobamamide Supplements in Malnourished Patients

Start date: July 2023
Phase: N/A
Study type: Interventional

The trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.

NCT ID: NCT05917418 Not yet recruiting - Malnutrition Clinical Trials

Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.

NCT ID: NCT05911893 Not yet recruiting - Undernutrition Clinical Trials

the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children

EHCONSGDMC
Start date: June 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effect of high caloric oral nutritional supplements on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in participants aged 1 to 3 years who are malnourished (underweight and wasting),as well as to evaluate the safety of applying high caloric oral nutritional supplements. Participants will receive nutritional education and daily high caloric oral nutritional supplements(experimental group),or will receive nutritional education and dietary instruction(control group).This study may provide data to support the development of clinical intervention strategies for malnourished Chinese children.

NCT ID: NCT05901766 Not yet recruiting - Breastfeeding Clinical Trials

Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment

Start date: November 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency. The main questions it aims to answer are: 1. What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials? 2. What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status? 3. How do iodine and iron interact with each other to affect thyroid function in the mother during pregnancy and lactation? Participants will be randomized to receive a daily multiple micronutrient tablet containing iodine (UNIMAPP) for 6 months postpartum, or routine care (iron-folic acid for 1 month postpartum). Mothers will provide a breast milk sample and drop of blood at 3 and 6 months postpartum. Infants will provide a urine sample and drop of blood, and have a neurodevelopmental assessment at 3 and 6 months. Researchers will compare the groups that received the iodine-containing micronutrient supplement with the group that received routine care (IFA) and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.

NCT ID: NCT05893446 Not yet recruiting - Clinical trials for Malnutrition; Protein

Essential Connections: Hospital to Community Impacting Malnutrition Outcomes in Older Adults

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Meal provision organizations, whether they provide meals within the home or in congregate centers, provide an excellent opportunity to address malnutrition by providing nutrition care and meals to those who are most vulnerable. Data has shown that nutrition care within the home by a dietitian can increase energy, protein intake, and body weight. The goal of this study is to test a new model for continuity of nutrition care for malnutrition treatment across settings and determine if it improves food security and quality of life in patients 60 years and older. The study will specifically recruit sites and a sample that represents individuals who have malnutrition, have experienced or are at risk for food insecurity, and those from rural areas as well as Black, Latino, Indigenous and Native American populations with a goal sample size of 1,120 patients over the five-year duration. The objectives of this study are to: 1) test the feasibility of a patient identification, cross-referral, data reporting, and communication process from an acute care hospital to a community meal provision organization; 2) identify barriers to and facilitators for implementation as well as costs of the new model of continuity of nutrition care across settings; and 3) improve food security, determinants of malnutrition, and quality of life in persons older than 60 years of age discharged from the hospital with a diagnosis of malnutrition. Level 1 evidence will be generated from the study. The outcomes to be measured are program sustainability, percent change in referrals, food insecurity, malnutrition risk and diagnosis, and quality of life. The results of this study can provide a new model for nutrition care that may improve food security, quality of life, and health outcomes.

NCT ID: NCT05890378 Not yet recruiting - Malnutrition, Child Clinical Trials

Integrated Livestock Management for Nutrition in Children Under Five Years of Age in Chad

Start date: July 2023
Phase:
Study type: Observational

The main objective of this study is to determine the effectiveness of a livestock management intervention, with considerations for animal food security, water contamination from animals, and nutrition counseling, in reducing the risk of acute malnutrition among children under the age of 5 years in Kanem and Bahr El Ghazel (BeG) in Chad.

NCT ID: NCT05860556 Not yet recruiting - Sarcopenia Clinical Trials

Sustainable Eating Pattern to Limit Malnutrition in Older Adults

SENIOR
Start date: September 2023
Phase:
Study type: Observational

The SENIOR STUDY is aimed at improving the condition of older adults and malnutrition management in and out Italian hospital settings, since malnutrition is highly prevalent, clinically relevant and potentially treatable condition. This study consist of two phases: an initial cross-sectional phase and a secondary nutritional intervention phase (RCT). The SENIOR CROSS-SECTIONAL study aims to map malnutrition status in accordance with the most recent GLIM criteria and investigate the association between malnutrition and anthropometric, demographic and socioeconomic, and lifestyle factors. In addition, sarcopenia will be diagnosed (EWGSOP2 consensus criteria) and blood markers will be measured. Malnutrition in Italian hospital setting is highly prevalent but the current malnutrition data prevalence and the general characteristics of older adults are not updated. Thus, it is expected to find a high malnutrition prevalence and an inadequate nutritional status.