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Child Nutrition Disorders clinical trials

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NCT ID: NCT06425523 Not yet recruiting - Malnutrition Clinical Trials

Transforming Health and Resilience In Vulnerable Environments: Mental Health, Psychosocial Support, and Climate-Smart Farming in Nakivale

THRIVE
Start date: July 2024
Phase: N/A
Study type: Interventional

The study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. It is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in Nakivale refugee settlement in Uganda. The mothers will be randomly assigned to one of three groups: - Control group: Mothers will receive Enhanced Usual Care (EUC). - HGI group: Mothers will receive the Home Gardening Intervention, consisting of training and supplies for home gardening. - HGI/SH+ group: Mothers will receive both the Home Gardening Intervention and the Self-Help Plus mental health intervention. The main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the EUC control group. It also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention. Secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups. The study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. Both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). Additionally, the study will assess childrens' wellbeing and functioning. Children will also be asked to carry out gamified tasks designed to measure their cognitive development.

NCT ID: NCT06414200 Not yet recruiting - Malnutrition, Child Clinical Trials

Nutritional Care After Discharge in Children Term Born-18years Old

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

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

NCT ID: NCT06397118 Not yet recruiting - Sickle Cell Disease Clinical Trials

Prevention of Malnutrition in Children With Sickle Cell Disease

PMC-SCD
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06380504 Not yet recruiting - Malnutrition, Child Clinical Trials

Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia

R-SWITCH
Start date: April 29, 2024
Phase: N/A
Study type: Interventional

The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness.

NCT ID: NCT06356220 Not yet recruiting - Clinical trials for Celiac Disease in Children

GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

GF-NOURISH
Start date: July 2024
Phase: N/A
Study type: Interventional

The investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits

NCT ID: NCT06155474 Not yet recruiting - Child Malnutrition Clinical Trials

Effects of Prebiotics on Metagenomic Diversity and Abundance in Young Children With Acute Malnutrition

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

Malnutrition is a major global public health issue, contributing to poor health and early morbidities in children under five, particularly in developing countries. In 2021, 5 million children died worldwide due to infectious diseases or malnutrition, with Pakistan having the highest under-five mortality rate. With a population of approximately 229 million, Pakistan is the fifth most populous country in the world. In Pakistan, under-five mortality is 63.3 per 1000 live births which has declined from 139.8 in 1990 to 63.3 in 2021 (WHO, 2022, UNICEF, 2023). The monsoon season's massive flooding in Pakistan has worsened the humanitarian situation, endangering the already vulnerable population. UNICEF reports high rates of acute malnutrition, political instability, economic decline, and coronavirus disease 2019 effects. However, there is limited evidence on the efficacy of probiotics for infants in Pakistan. Metagenomics is the study of microorganisms' genomes, examining all microorganisms in an ecological site's genomes. It involves extracting and sequencing DNA using high-throughput techniques. Scientists can identify genes with significant features using computer analysis. The distal intestine contains around one trillion organisms per milliliter of luminal contents, and understanding their potential for energy and nutrient harvest is crucial in malnourished individuals. Alpha diversity is the analysis of species diversity in a sample, measured by observed species index, Chao1 index, Shannon index, Simpson index, and good-coverage index. It is proportional to the first four values and indicates less undiscovered species. The distal intestine contains around one trillion organisms per milliliter of luminal contents, with an increased capacity for energy harvest in malnourished individuals. The present study aims to measure the following objectives. i. -To estimate the microbiome degree of diversity among malnutrition children micro-biota defined by 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing. ii. -To evaluate the interpersonal differences in the structure and functioning of the gut microbiome that affect a person's vulnerability to malnutrition. iii. -To determine how microbiomes are shaped by host genotypes, environmental exposures, including exposure to malnutrition in children mothers, and other family members, nutritional status, and lifestyles, including diet.

NCT ID: NCT06102473 Not yet recruiting - Clinical trials for Overweight and Obesity

Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.

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

The goal of this clinical trial is to evaluate the effect of a digital educational intervention of front-of-package warning labeling on the selection and purchase of food in elementary school children and their caregivers. The main question it aims to answer is: - What is the effect of a digital educational intervention on front-of-package warning labeling on food selection in children from primary schools in Mexico City, compared to a control group? Participants will be randomized into two groups. - The control group, the dyads (caregiver-schoolchildren), will receive general nutritional education. - The intervention group, will also receive guidance on reading labels and raise awareness about the impact of consuming processed or ultra-processed foods on health. The intervention will be carried out through a web page with audiovisual material and all participants also will be asked to complete: - Multiple-choice evaluation (5 questions) to ensure theoretical understanding of the topics - Lunch register - 24-hour dietary recall - Survey of food habits and consumption - Validated food preference questionnaire - Anthropometric measurements (Weight, height, waist circumference, body mass index) - Socioeconomic survey - Participate in a simulated online selection and shopping of food and beverages. To see if the digital educational intervention in the front of package warning labeling in children and caregivers will improve the selection and purchase of foods.

NCT ID: NCT06065904 Not yet recruiting - Clinical trials for Nutrition Disorder, Child

Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD

Nutrilect
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The study is a prospective, single-center, randomized controlled trial that will be conducted at the Medical University of Varna. This setting offers access to a wealth of clinical expertise in managing CP and ASD and a rich tradition of conducting robust nutritional interventions.

NCT ID: NCT06049680 Not yet recruiting - Malnutrition Clinical Trials

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

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

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.

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.