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Child Nutrition Disorders clinical trials

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NCT ID: NCT06382857 Recruiting - Malnutrition, Child Clinical Trials

Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

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

This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to < 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.

NCT ID: NCT06287827 Recruiting - Child Malnutrition Clinical Trials

Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research

Start date: February 14, 2024
Phase:
Study type: Observational

The goal of this observational study is to compare the effectiveness, safety, and efficiency of the simplified protocol, which includes the following three modifications: a) use of a single treatment product (RUTF), b) reduced dose, c) expanded cut-offs, with the standard protocol based on the 2023 World Health Organization (WHO) guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months, in outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela. The main question it aims to answer is: What is the effectiveness, safety, and efficiency of the simplified protocol, which includes these three modifications (use of a single treatment product (RUTF), reduced dose, expanded cut-offs) when compared to a standard protocol that is based on the 2023 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in the outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela? This prospective cohort, longitudinal study will be conducted in 4 states, treating children aged 6-59 months diagnosed with uncomplicated AM, defined as WHZ <-2 or mid-upper-arm circumference (MUAC) <125mm or bilateral edema. Children will be prospectively followed for 16 weeks or until their recovery. Researchers will compare the simplified protocol cohort with the standard protocol cohort to determine which one has the best effectiveness, safety, and efficiency indicators in the Venezuela context. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment, and changes in anthropometry (weight, height, and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death, and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.

NCT ID: NCT06175273 Recruiting - Pediatric Cancer Clinical Trials

Pediatric Oncology Nutrition Intervention Trial

POINT
Start date: January 31, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Nearly 60% of pediatric patients diagnosed with cancer develop malnutrition caused by a combination of disease burden, side effects of chemotherapy, and the intensity of cancer treatment. These patients are known to have an increased risk of infection, treatment-related toxicity, inferior clinical outcomes, and increased risk of mortality. Malnutrition may progress to cancer cachexia, characterized by anorexia, increased inflammation, decreased fat, and decreased muscle mass with subsequent weight loss, which is associated with decreased overall survival. The goal of the proposed research is to determine changes in body composition, weight status, and nutritional status between common nutrition interventions including oral nutrition supplements (ONS), appetite stimulants, and enteral nutrition (EN) among pediatric cancer patients. A secondary goal of this research is to utilize the findings to develop clinical nutrition guidelines for this patient population. The specific objective of the research proposed is to solve the lack of evidence to adequately treat nutritional deficits in the pediatric oncology population. Without this data, there is a lack of clinical consistency in the initiation and selection of appropriate nutrition interventions to provide a more definitive pathway of care. This study can help formulate a clinical guideline for this patient population before, during, and after treatment.

NCT ID: NCT05889520 Recruiting - Child Malnutrition Clinical Trials

The UFIM (Ultraprocessed Foods In Breast Milk) Project

UFIM
Start date: May 23, 2023
Phase:
Study type: Observational

In last decades, a change in dietary habits has been observed in industrialized countries characterized by a drastic increase in the consumption of ultra-processed foods (UPF, Ultra-Processed Foods). As defined by the NOVA classification, UPFs are industrial formulations of food substances added with colourings, flavourings, emulsifiers, thickeners and other additives. Among the main compounds of UPFs are the advanced glycation end-products (AGEs). Increasing evidence suggests an association between dietary exposure to AGEs and the development of chronic non-communicable diseases, such as obesity and allergies, in the general population, through increased oxidative stress and inflammation. Preliminary evidence suggests that a maternal diet rich in AGEs during pregnancy and lactation could negatively influence the composition of breast milk and have a negative impact on the infants health. However, data regarding the presence of derivatives of UPFs in breast milk are not available. The UFIM (Ultraprocessed Foods In Breast Milk) study aims at evaluate the presence of UPFs-derivatives compounds in breast milk.

NCT ID: NCT05836961 Recruiting - Clinical trials for Iron Deficiency Anemia

Impact of Benazir Nashonuma Program (BNP) on Maternal and Child Nutritional Status

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

The purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. The study aims to answer if: 1. Utilization of Benazir Nashonuma Program (BNP) among pregnant women is effective in reducing the proportion of low birthweight babies, compared to pregnant women who are not utilizing the program, among low income setting population. 2. Utilization of Benazir Nashonuma Program (BNP) is effective in reducing the proportion of stunting among children, compared to those not utilizing the program, among low income setting population. Participants who are enrolled in the Benazir Nashonuma Program (receiving intervention) and those who are not enrolled (not receiving intervention) will be followed throughout pregnancy till delivery. After delivery mother-baby dyad will be followed for a period of 12 months. Compliance of supplementation will be measured, and outcomes (low birthweight and stunting) observed throughout the follow up.

NCT ID: NCT05791305 Recruiting - Obesity Clinical Trials

Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years

DBM
Start date: April 10, 2023
Phase: N/A
Study type: Interventional

Background: Double burden of malnutrition is an emerging public health problem among children under-five years due to the inevitable consequences of nutritional transition. Addressing these two contrasting forms of malnutrition (undernutrition and overnutrition) simultaneously brings an enormous challenge to the food and nutrition policies of developing countries like Ethiopia. Children under five ages are more vulnerable to DBM, especially during the first year of their life due to high growth and inadequate diet. Hence, there has been a paradigm shift in thinking to reduce its effect on the health of children. However, interventions that are used to address these different kinds of malnutrition are implemented through different governance and still, they are isolated and disintegrated each other. Therefore, double-duty interventions can tackle the risk of both nutritional problems simultaneously in an integrated approach through nutrition behavior change communication. Objective: Therefore, the main aim of this pilot study is to assess the effect of selected double-duty interventions on the double burden of malnutrition among children under five years in Debre Berhan City, Ethiopia.

NCT ID: NCT05774314 Recruiting - Child Malnutrition Clinical Trials

The Impact of Community Health Workers on Child Malnutrition in the Philippines

Start date: July 11, 2023
Phase: N/A
Study type: Interventional

This study will focus on a new community health worker (CHW) program called 'Flourish', which is implemented by Philippine non-governmental organization (NGO) International Care Ministries (ICM). ICM's core program is 'Transform', which is a poverty alleviation program that focuses on households living in ultra-poverty (less than 0.50 United States dollars (USD) per person per day). Transform leverages local community networks to identify 30 participants from the most marginalized households in the community. ICM then provides these participants with 15 weeks of health and livelihood education, as well as with health interventions, including childhood malnutrition treatment. In ICM's Flourish program, one of the 30 participants in each Transform program is nominated by their peers to become an ICM-supported CHW. The CHWs will not only provide health services after the conclusion of the Transform program for their fellow Transform participants' households, but they will also serve an additional 50+ households in their communities. These additional 'non-Transform' households will be identified by asking the Transform participants to nominate peers in their social networks that share similar socioeconomic backgrounds and whose households are perceived to also benefit from CHW services. The primary aim of this research is to assess the impact of CHWs on the prevalence of acute childhood malnutrition in hard-to-reach households within low-income communities. The investigators hypothesize that this study will show that CHWs are able to reduce the prevalence of acute childhood malnutrition in hard-to-reach households within low-income communities.

NCT ID: NCT05629624 Recruiting - Malnutrition, Child Clinical Trials

Evaluation of Executive Function and Emotional Regulation in Children in Bangladesh

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The study explores the impact of malnutrition at enrollment on executive function (EF) and emotional regulation (ER) in malnourished 1-year-old children and whether specially designed brain directed therapeutic feeds improve EF/ER outcomes at three years of age. The study will detect changes in EF and ER related to nutritional rehabilitation using specially designed ready to use therapeutic feeds (E-RUSF Nutriset) during the repletion phase and maintained for two years until age 3 with enhanced E-SQLNS (small quantity lipid based nutrient supplement) also modified to provide adequate brain directed micro and macronutrients. The investigators hypothesize that standard Bangladeshi designed B-RUSF and SQLNS (Nutriset) do not provide adequate nutrients to supply the brain during the rapid catch-up growth and subsequent early childhood growth phases of rehabilitation from Moderate Acute Malnutrition (MAM). The investigators predict that the children with moderately severe malnutrition treated with E-RUSF followed by 2 years of E-SQLNS will show an exuberance of connections (higher functional connectivity) than children receiving standard Bangladeshi rehabilitation feeds B-RUSF and SQLNS. This prediction is based on past work using EEG to examine the BEAN sample in Bangladesh, and differs from the sample in Boston, where the investigators anticipate that among healthy, normally nourished children, greater connectivity will be associated with better cognitive outcomes. The Core Toolkit will be deployed to the Bangladesh site to define its utility in prediction of executive dysfunction and emotional dysregulation in the context of low-income status, malnutrition and nutritional intervention. All nutritional intervention groups of malnourished children will also receive a set psychosocial stimulation curriculum that has been shown to be effective on severely malnourished children with therapeutic feedings.

NCT ID: NCT05519254 Recruiting - Diarrhea Clinical Trials

Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

Start date: March 10, 2023
Phase: Phase 3
Study type: Interventional

Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or "ORS"). This study will test whether nutritional supplements made from milk (lactoferrin or lysozyme) or a combination of the two (lactoferrin and lysozyme) will prevent children from having repeated diarrhea episodes and help improve their nutrition by improving their stomach health or preventing new disease during this 6-month period. The study is taking place at 7 hospitals in Western Kenya. Six hundred participants will be enrolled if they provide informed consent to participate, are aged 6-24 months, were hospitalized with diarrhea and malnutrition and have been managed by the facility nutritionists and ready to return home. Participation in the study will entail providing information on the child's health history, collection of stool samples, blood, and potentially urine. The caregiver will be provided sachets of the investigational product to take home and mix daily with their child's porridge or other complimentary food, and asked to return to the clinic 4 times in the subsequent 6 months, and also consent to having a community health worker visit their home every two weeks for a follow up visit. The risks to the participant and their caregiver are minimal. The information gained in this study will help us create new treatments and develop new strategies to treat sick children to prevent death and illness.

NCT ID: NCT05473312 Recruiting - Health Behavior Clinical Trials

Women Supporting Women to Improve Infant and Child Feeding Practices

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Undernutrition in the first 2 years of life is the largest preventable cause of death before age 5. Among those who survive, stunting before age two leaves millions with lifelong physical and cognitive deficits, which are difficult to compensate for later in life. Pakistan is home to the second largest number of stunted children in South Asia. The primary goal of this study is to rehabilitate moderately malnourished children aged 7-23 months and enable mothers to sustain this healthy growth at home by changing their infant and young child feeding (IYCF) practices, child care, hygiene and health-seeking behaviours.