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Showing 1-20 of 444 trials
NCT06397118
The investigators are studying how to prevent malnutrition in children with sickle cell disease (SCD) in northern Nigeria. Community health workers will teach mothers about nutritious local foods that might help children grow better than the usual advice from doctors. The investigators will enroll 148 children with SCD aged 6 to 18 months old. The investigators will determine if their weight and diet improve and check for low vitamin A levels. This information will help us find better ways to improve growth for children with SCD.
NCT06207071
Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.
NCT04536974
The goal is to find a simple tool that can be used by medical and paramedical staff and that is reliable to identify children at risk for malnutrition.
NCT06414200
The goal of this stepped wedge cluster randomized trial is to compare nutritional care after discharge to an intervention in children term born - 18 years old discharged with newly initiated nutritional care. The main question it aims to answer is: To investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life (QoL) in children and their parents. Furthermore, the effect on parental stress, anxiety, depression, and post-traumatic stress (PTSD) as well as QoL will be assessed with and without a tailored nutritional care follow-up program
NCT05853874
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 conditions. This study consist of two phases: an initial cross-sectional phase and a secondary nutritional intervention phase (RCT). The SENIOR RCT aim to evaluate the efficacy of a 6 months nutrition protocol intervention compared to hospital standard care on malnourished older adults. Physical and nutritional status will be evaluated through anthropometric measures, blood exams and physical performance. In addition, the individual health perception will be evaluated. It is expected to find an improvements of the physical and nutritional status.
NCT07565415
Primary Objective: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on body weight and appetite in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Secondary Objectives: To evaluate the effect of nanocrystalline megestrol acetate versus placebo on quality of life, inflammatory markers, nutritional indicators, and psychological stress in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.Exploratory Objective: To explore the impact of nanocrystalline megestrol acetate versus placebo on survival benefit in patients with unresectable hepatocellular carcinoma receiving TACE combined with targeted and immunotherapy.
NCT06345547
The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are: * what is the prevalence and development of sarcopenia in cirrhosis? * what is the role of malnutrition? Participants will * undergo a muscle ultrasound of the lower and upper limb muscles * handgrip strength will be measured * malnutrition screening and assessment * complete a questionnaire to assess quality of life
NCT06902402
The goal of this clinical trial is to demonstrate safety and efficacy of Supportan® Drink (three flavors:Tropical Fruits, Cappuccino, and Pineapple-Coconut), administered as oral nutritional supplement, that will be taken in addition to the patient's normal dietary intake to meet the daily nutritional targets. in cancer patients. The main questions it aims to answer are: Primary Efficacy Endpoint 1. Change in body weight from Baseline to end of treatment at Week 4 (Week 4 -Baseline) Secondary Efficacy Endpoints 1\. Change in CRP from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 -Baseline) Participants will be enrolled in one of three flavor group by his/her recruiting time. Each subject needs visit hospital at baseline, week 2 and week 4 for checkups and test. And he/she needs take two bottles of Supportan Drink per day. During the study periods, subjects need write down his/her dietary records every day for evaluation.
NCT06846749
The goal of this clinical trial is to learn if giving lower calorie feeds during the first stage of treatment helps improve survival in severely malnourished children who are ill. The main question it aims to answer is: Is it safe to feed ill severely malnourished children lower calorie feeds during the early treatment phase? Researchers will compare two lower calorie feeds (F50 and F35) to the standard feed (F75) to see if they help children recover safely without increasing their risk of low blood sugar (hypoglycemia). Participants will: * Receive one of the lower calorie feeds (F50 or F35) or the standard feed (F75) during their hospital stay. * Be closely monitored for low blood sugar and signs for worsening of clinical symptoms. * Be treated until they are stable and ready to be fed more calories to help them gain weight.
NCT05269992
A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement).
NCT05257980
The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the four ONS for 28 days alongside their routine diet.
NCT07504419
This international multicenter study project. A physical function screening activity for the elderly will be held in the community centers. After screening out high-risk subjects for frailty, they will be guided to participate in motivational interviews. Design thinking is used to design product/service processes based on nutritional problems, and combined with the nutritional care process.
NCT07504133
Malnutrition is a major public health concern among children in developing countries, leading to impaired growth and increased risk of morbidity. This study evaluated the effectiveness of nutrient-dense composite flour cookies as a dietary intervention to improve the nutritional status of malnourished children. Composite cookies were developed using soy, chickpea, and peanut, and were subjected to nutritional and quality analysis including proximate composition and other physicochemical assessments prior to intervention. A randomized controlled trial was conducted among 60 malnourished children aged 3 to 10 years, divided into intervention and control groups. The intervention group received the composite cookies along with their regular diet, while the control group continued with their usual diet. Anthropometric indicators including weight, body mass index (BMI), and mid-upper arm circumference (MUAC), as well as biochemical parameters such as hemoglobin and serum albumin, were assessed at baseline and after a 3-month intervention period. The study aimed to determine whether supplementation with nutrient-rich composite cookies could significantly improve growth and nutritional outcomes in malnourished children.
NCT07225153
The goal of this clinical trial is to learn if Goat Milk-Derived Formula Alternatives (GMDFA) are safe and effective for infants who are unable to be exclusively breastfed. It will also study growth patterns, biological markers, and gut microbiome differences among infants receiving GMDFA, undiluted goat milk, or breast milk. The main questions it aims to answer are: 1. Do infants receiving GMDFA show similar growth patterns to those who are breastfed? 2. Are biological markers of gut health and nutrition (such as calprotectin, lipocalin-2, CRP, and claudin) comparable between the groups? 3. How do feeding types (GMDFA, goat milk, or breast milk) influence the infant gut microbiome composition, metabolic pathways, and lipid profiles? 4. Is GMDFA a safe and nutritionally adequate feeding option for infants unable to be exclusively breastfed? We will compare GMDFA, undiluted goat milk, and breast milk (reference group) to evaluate infant growth, gut health, and metabolic outcomes. Participants will: Be randomly assigned to one of three feeding groups: GMDFA, undiluted goat milk, or breastfed Attend regular follow-up visits for growth measurements and sample collection (blood, stool, and breast milk where applicable) Have feeding practices monitored and recorded through caregiver interviews and feeding logs Additional Analyses: Microbiome analysis: to identify gut bacterial diversity and composition across feeding groups Metagenomic analysis: to explore functional genes and metabolic pathways related to nutrition and gut health Lipidomic analysis: to assess differences in lipid and fatty acid profiles in breast milk, goat milk, and infant samples
NCT06441305
Child wasting is a type of malnutrition which occurs when a child becomes too thin. This medical condition increases the risk of becoming sick or dying. A child with severe wasting needs to be seen in a medical consultation to check on health status and to receive some medicine and a medical food supplement for daily consumption until cured. Yet, only a small proportion of children suffering from severe wasting are presently receiving appropriate treatment. In Kenya, there is an opportunity to build on the existing network of community health promoters (CHPs) to increase the number of children with wasting who are identified and treated. In intervention areas, CHPs will be equipped with smartphones and an application which provides guidance on household members to visit and simple actions to take, related to health. CHPs will distribute color-coded mid-upper arm circumference tapes to households with young children and train caregivers on how to use it. After training, CHPs will send Short Message Services (SMS) to remind caregivers to regularly measure the arm circumference of the child. In addition, CHPs will receive a scale to measure the weight of children every month. Finally, wasted children registered in the treatment program who fail to attend a planned consultation will be flagged to their CHP through the phone application, and CHPs will conduct a specific home visit to investigate and help solve potential issues. The study will assess whether this community intervention (called SWITCH) allows to identify and treat more children suffering from severe wasting. Before the start of the intervention, the proportion of wasted children receiving treatment in 40 community units in Turkana South, Turkana East and Aroo will be assessed. After this survey, a computer will randomly select 20 community units where the intervention will be scaled up. The survey will be repeated after 2 years to assess if the proportion of severely wasted children receiving treatment is higher in the area where the intervention was scaled up compared to the area where it was not scaled up. In addition, after 1 year of implementation, the study will assess how the intervention was scaled up, what are the main challenges, and what are the overall perceptions on the intervention in the community among those who receive it and those who deliver it. Finally, costs of the various components of the intervention will be measured for all actors involved, including for caregivers.
NCT05994742
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 comparing an antimicrobial intervention with standard of care.
NCT06154174
The goal of this clinical trial is to test adding choline to ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition (SAM) in Malawi. The main question it aims to answer is: \- Will the addition of a 500mg daily dose of choline to RUTF during treatment for SAM improve cognitive development among 6-59-month-old Malawian children compared with standard RUTF without added choline?
NCT06599593
In the Sahel, the malaria and malnutrition seasons overlap during the rainy season, from approximately July through October. Malaria transmission increases due to the rain and collection of standing water and malnutrition risk increases because this period is the growing season, leading up to the annual harvest in November. Seasonal malaria chemoprevention (SMC) is an antimalarial intervention that involves monthly distribution of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) to children aged 3-59 months during the high malaria transmission season. SMC is distributed to millions of children annually in 13 countries in the Sahel, including Burkina Faso. Although SMC distribution is highly effective against clinical malaria in children, malaria remains a major cause of childhood mortality and morbidity in Burkina Faso. The SMC platform, which involves monthly door-to-door delivery of SP-AQ, is an attractive platform for delivery of additional interventions that may augment child health during this vulnerable season. Malaria and malnutrition co-occur in children and communities, and interventions for one may affect the other. For example, previous work by our group and others has shown that antimalarial treatments may improve weight gain in children with malnutrition. The pilot trial is designed to evaluate how the SMC platform may be leveraged to deliver co-interventions with SMC that may augment its efficacy and reduce the incidence of malaria and malnutrition. It is anticipated that the results of this study will provide formative data for the development and implementation of a full-scale study evaluating the effects of integration of nutritional interventions on the SMC platform. It is anticipated that such a strategy may provide optimal protection for children during the most vulnerable period of the year by delivering interventions monthly on an existing platform that directly reaches millions of children each month.
NCT05919940
Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients. The study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline. The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.
NCT07433946
This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers. IBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk. Participants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal/day) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA/BIVA, vitamin B12/D, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score). The study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.