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Malnutrition, Child clinical trials

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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: NCT05442424 Recruiting - Obesity Clinical Trials

Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii

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

Children living in food-insecure homes, defined as at some time during the last year their household not having enough food, money, or resources to feed the family experience low intake of fresh fruits and vegetables (FV), and a trajectory for increased risk of obesity and chronic diseases in adulthood. In Hawai'i, a higher proportion of Native Hawaiian (NH) and other Pacific Islander (OPI) children live in food-insecure households when compared with the state average (30% and 50%, respectively vs. 18%) and NHOPI adults suffer disproportionately from chronic disease. Produce prescription programs, provide vouchers to individuals to purchase fresh FV, are promising strategies to improve diet quality and reduce chronic disease risk among food insecure populations. The long-term objective of this research is to reduce nutrition-related health disparities via clinical-community based programming. The Keiki (child) Produce Prescription (KPRx) program was developed and implemented by enlisting University and community researchers and health care providers at the Waianae Coast Comprehensive Health Center (WCCHC). The current study builds on the community-academic partnership to achieve the following specific aim, to measure effectiveness of the KPRx on FV intake, gut microbiome composition, and health related biomarkers in 100 parent-child dyads in the context of household food insecurity from a predominantly NHOPI community in Hawai'i. A community based participatory research approach to carry out a randomized controlled trial that measures the effect of the KPRx on child diet and microbiome, and parent/caregiver diet and health-related biomarkers on 100 parent-child dyads in the context of household food insecurity will be conducted. The community-informed research study will provide data to inform local and state healthcare and nutrition assistance programming policies aimed at reducing food insecurity and health disparities among NHOPI and minority populations.

NCT ID: NCT05437068 Withdrawn - Malnutrition, Child Clinical Trials

Nutritional Supplementation in Children at Risk of Undernutrition

Start date: November 11, 2022
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.

NCT ID: NCT05269992 Recruiting - Malnutrition, Child Clinical Trials

Childrens Real Food Tolerance Study

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

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).

NCT ID: NCT05254444 Active, not recruiting - Malnutrition, Child Clinical Trials

Samaki Salama: Small-scale Fisheries for Healthy Nutrition and Ecosystems

Start date: July 9, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effectiveness of a bundled intervention to address malnutrition and its intersections with nutrition security and fisheries sustainability in Kilifi, Kenya.

NCT ID: NCT05123378 Active, not recruiting - Malaria Clinical Trials

Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Last Mile Health (LMH) has partnered with the Liberian Ministry of Health (MOH) to support the design and implementation of the National Community Health Assistant Program (NCHAP). In collaboration with MOH, LMH is planning to conduct an impact evaluation in Grand Bassa to assess the effect of the National Community Health Assistant Program (NCHAP) on health outcomes, as well as to learn lessons around program operations and implementation. Our central hypothesis is that Community Health Assistants (CHAs) within the NCHAP will reduce under 5 mortality, as a result of expanding access to and uptake of health care utilization in remote communities. We will use a mixed effects discrete survival model, taking advantage of the staggered program implementation in Grand Bassa districts over a period of 4 years to compare the incidence of under-5 child mortality between the pre- and post-CHW program implementation periods.

NCT ID: NCT05051163 Recruiting - HIV-1-infection Clinical Trials

Strategies to Reduce Mortality Among HIV-infected and HIV-exposed Children Admitted With Severe Acute Malnutrition

REDMOTHIV
Start date: June 14, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study to investigate whether empiric use of an antibiotic with greater antimicrobial sensitivity (ceftriaxone) than standard-of-care (ampicillin plus gentamicin) will reduce mortality among HIV-infected/HEU children admitted to Mwanamugimu Nutrition Unit, Mulago Hospital, Kampala, Uganda.

NCT ID: NCT05044910 Active, not recruiting - Tuberculosis Clinical Trials

The Impact of Malnutrition on Immune Responses to Tuberculosis

TBMAM
Start date: August 1, 2020
Phase:
Study type: Observational

The aim of this study is to assess immune responses to Mtb in children with MAM compared to well-nourished children and to evaluate the impact of a nutrition intervention on these immune responses.

NCT ID: NCT05012592 Completed - Malnutrition, Child Clinical Trials

Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses

Start date: September 17, 2021
Phase: N/A
Study type: Interventional

Title: Reducing malnutrition and helminthic infectious disease among primary school children by the school nurses: School-based non-randomized study in a developing country Introduction: Globally, malnutrition alone with the infectious disease a widespread problem among primary school (5 to 12 years) children. Infectious diseases such as worm infestations are aggravated with nutritional disorders which most often lead to anemia and several complications. The prevalence of malnutrition and intestinal worm infestation/ helminthic infection is still high and the awareness level of those issues is immensely poor. However, there are limited studies that evaluated the impact of increasing health awareness by the development of the Health Awareness Program for Primary School Children (HAPSC) which is conducted by the experimentally placed school nurse in Bangladesh. Objective: To increase health awareness and knowledge towards reducing malnutrition and intestinal worm infestation by implement and evaluate the impact of the Health Awareness Program for Primary School children (HAPSC) in Bangladesh. Methods: Design: A prospective, open-label, parallel-group (1:1), cluster non-randomization controlled trial (NRCT) Site and sample: School children from four primary schools in the rural areas of North Matlab at Chandpur district at Chittagong division in Bangladesh. Duration: The duration of this study is from August 2021 to March 2024 (32nd months). Outcome variables: Primary: changes in malnutrition among primary school children. Secondary: Evaluate and reduce the prevalence of intestinal worm infestation, increase awareness and knowledge regarding malnutritional and intestinal worm infestation, improvement of health behavior (eating and hygiene), frequency of school absent days, and health-related quality of life. Conclusion: Health education by the health professional in the school setting may be an effective method for improving health behavior, and increasing awareness and knowledge levels about malnutrition and intestinal worm infestation from early childhood.

NCT ID: NCT04915638 Completed - Clinical trials for Overweight and Obesity

Intervention in Children With Malnutrition

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Malnutrition is an epidemiologic problem with high prevalence in Mexico. Mexican children present a double burden of malnutrition characterized by the coexistence of undernutrition and micronutrient deficiency alongside excess body weight. Malnutrition is caused by inadequate nutrition, including micronutrients deficiencies, in which children living in rural areas and indigenous populations are disproportionately affected. Malnutrition has been associated with an increased risk of metabolic abnormalities like metabolic syndrome (MS), diabetes, and cardiovascular disease in adulthood. Nutrition-specific interventions are strategies that may reduce or avert malnutrition in children. However, limited intervention studies have been implemented in low-income populations, particularly in rural areas. Therefore, studies that include nutrition-specific intervention with enriched foods aimed at reducing micronutrients deficiencies and that can help in prevention or treatment of metabolic conditions in these populations are still needed. Based on the nutritional characterization carried out in school children in Chimalhuacán, Mexico State, a formula in a powder form was designed for children containing vitamins, minerals, antioxidants, and omega-3 fatty acids that can be used to enrich foods. The present study aimed to evaluate the effect of a 4-week intervention with cookies enriched with a micronutrient formula on the nutritional status in Maya schoolchildren aged 8-10 years. Participants (n=84) were their own control, and the investigators measured, at pre- and post-intervention, anthropometric, clinical, biochemical, and cognitive parameters; diet and molecular parameters were assessed only at pre-intervention. Chi-square test, t-Student paired or Wilcoxon, ANCOVA, and logistic regression were performed to analyze the data.