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Child Malnutrition clinical trials

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NCT ID: NCT06329388 Completed - Child Development Clinical Trials

Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns

Start date: January 18, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device.

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: 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: 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: March 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: 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: 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: NCT05726422 Terminated - Child Malnutrition Clinical Trials

Use of a 10 Points Visual Analogue Food Intake Scale for Children to Assess Intake: Prospective Study

CESAR
Start date: February 27, 2023
Phase:
Study type: Observational

In hospitalized children, undernutrition increases the length of hospitalization, aggravates the causal pathology, favors the occurrence of complications, and increases the cost of hospitalization. With a prevalence of 10 to 20%, undernutrition is therefore a major problem which, moreover, is largely under-diagnosed. The evaluation of food intake has historically been based on the evaluation of food consumption by means of a food card or a food survey during the last 24 hours. In adults, a rapid assessment tool has been developed, the SEFI® (Score Evaluation Facile des Ingestats), consisting of a visual analog scale (VAS) graduated from 0 to 10. It has been validated as being concordant with previous tools for the assessment of dietary intake in the general population and is now recommended for adults. It allows early identification of a risk of undernutrition when the score is < 7/10. We propose to evaluate the correlation between this 10-point analog scale (SEFI) and ingesta in children in relation to recommended energy intakes for age and weight.

NCT ID: NCT05543759 Terminated - Child Malnutrition Clinical Trials

Simplified Treatment Protocol for Acute Malnutrition in Venezuela

Start date: September 5, 2022
Phase:
Study type: Observational [Patient Registry]

Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). This study has been designed to generate new evidence about the simplified combined protocol for the identification and treatment of GAM in Venezuela. The objective of the study is to document the safety and effectiveness of the Venezuelan simplified treatment protocol for GAM, which includes reduced frequency of follow-up visits, single product use and optimized daily RUTF dose. This prospective longitudinal study was conducted in 19 centers treating GAM in children aged 6-59 months diagnosed with uncomplicated GAM, defined as WHZ <-2 or MUAC <125mm or ++ bilateral edema. Children will be prospectively followed for a total of 6 months, including the treatment phase and the immediate post-discharge weeks until 6 months. 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: 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.

NCT ID: NCT05181293 Recruiting - Child Malnutrition Clinical Trials

Mobile Gaming App to Improve Child Nutrition in Nigeria

Start date: March 23, 2022
Phase: N/A
Study type: Interventional

Undernutrition among children born to teenage mothers deserves urgent attention in Nigeria, where 27.2% of girls (15-19 years) living in rural areas have begun childbearing. The overall goal of this study is to develop, validate and evaluate the effects of a mobile gaming app on the infant and young child feeding practices of teenage mothers, and the nutritional status of children (0 - 2 years).