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Malnutrition clinical trials

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NCT ID: NCT06372418 Not yet recruiting - Clinical trials for Breastfeeding, Exclusive

Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants

IBAMI-2
Start date: May 2024
Phase: N/A
Study type: Interventional

The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants. Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital.

NCT ID: NCT06362837 Not yet recruiting - Stunting Clinical Trials

Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services

REACTS-IN
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.

NCT ID: NCT06357910 Not yet recruiting - Healthy Clinical Trials

A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions

Start date: May 17, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers.

NCT ID: NCT06345547 Not yet recruiting - Sarcopenia Clinical Trials

Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

MMUSCLE
Start date: May 2, 2024
Phase:
Study type: Observational [Patient Registry]

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

NCT ID: NCT06330025 Not yet recruiting - Undernutrition Clinical Trials

Exploring Food Rejection Dispositions as Potential Risk Factors for Undernutrition in Hospitalized Children Aged 2 to 8

MEDIALIME
Start date: April 2024
Phase:
Study type: Observational

Undernutrition affects over 30% of hospitalized children in France, with 10% severely malnourished yet only half of the cases are diagnosed. Undernutrition deteriorates children's health during hospital stays, weakening immunity and hindering recovery. Children suffering from acute malnutrition can stay in the hospital 45% longer than non-malnourished patients. One of the primary causes of malnutrition is the reduction in children's food intake. Several researchers have emphasized that the young age of patients is associated with reduced food intake. For example, data on 923 children aged 1 day to 16 years indicates that patients under 8 years old are at a higher risk of undernutrition than older children. The MEDIC project aims to investigate if increased food rejection dispositions contribute to reduced food intake in hospitalized children. Food rejections are typically observed between 2 and 8 years. Some children are more challenging and eat only a few different foods, while others try everything. Around the age of 2, children become more selective about the foods they consume. This is largely due to two common dispositions in young children: food neophobia and food pickiness. Food neophobia is defined as the reluctance to eat or even try foods that appear new, whereas food pickiness is defined as the rejection of a substantial number of familiar foods, including foods previously tasted. Both pickiness and neophobia have been associated with a significant reduction in food consumption (especially of vegetables), a decrease in food variety, and less enjoyment derived from food. A study showed that children aged 2 to 5 were twice as likely to be underweight if they were picky eaters. Studies have shown that the socioeconomic status has a significant impact on food rejection in children. For instance, longitudinal studies reveal a higher proportion of picky eaters in low-income families. Parental education was also found to be inversely associated with children's food rejection levels. The MEDIC project seeks to assess health inequalities by studying the impact of food rejection dispositions on the nutritional status of children in pediatric services. A qualitative study supports the notion that food rejection is heightened during the hospitalization: half of the parents of hospitalized children interviewed reported that foods accepted outside the hospital were rejected in the ward. Parents indicated that their child's food preferences were more limited, and they only alternated between a few foods after entering the hospital. According to the majority of interviewed nurses, children refuse any food other than that provided by parents. The research hypotheses of the MEDIC project focus on understanding the moderating effects of food rejection dispositions and socioeconomic backgrounds on children's food intake during hospitalization. Two hypotheses are formulated: (H1) the pre-hospitalization food rejection levels predict the amount of food consumed during the hospital stay, and (H2) children from disadvantaged socioeconomic backgrounds are more likely to refuse food during their hospital stay than those from more advantaged backgrounds. To test these hypotheses, parents of children aged 2 to 8 will complete questionnaires on food rejection dispositions upon admission, and food consumption (in grams and calories) will be assessed through weighing and photographs of meal trays taken 48 hours (± 24 hours) post-admission. The project aims to shed light on the complexities of childhood malnutrition, addressing social inequalities and contributing valuable insights for interventions and public health policy.

NCT ID: NCT06316336 Not yet recruiting - Healthy Vollunteer Clinical Trials

Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions

BE24-005
Start date: June 10, 2024
Phase: Phase 1
Study type: Interventional

Objectives: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy subjects under fed conditions and To evaluate safety of test and reference formulations Study Design: An open label, randomized, two-treatment, two-period, two-sequence, multiple oral dose, crossover bioequivalence study in healthy Thai male volunteers under fed conditions with at least 7 days washout period between last dosing of Period 1 and first dosing of Period 2.

NCT ID: NCT06308848 Not yet recruiting - Clinical trials for Severe Acute Malnutrition

Microbiota Directed Food for Children With Severe Acute Malnutrition

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF.

NCT ID: NCT06305442 Not yet recruiting - Clinical trials for Moderate Acute Malnutrition

Microbiota Directed Food for Children With Moderate Acute Malnutrition

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food.we propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF.

NCT ID: NCT06277232 Not yet recruiting - Clinical trials for Overweight and Obesity

Nutrition Care in Patients Living With Chronic Pain

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

The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain. The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes.

NCT ID: NCT06274788 Not yet recruiting - Malnutrition Clinical Trials

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population