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Malnutrition clinical trials

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NCT ID: NCT05544318 Recruiting - Malnutrition Clinical Trials

Green Approach to Improved Nutritional Support for Cancer Patients

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

In this study, we aim to reduce the burden of malnutrition in cancer patients by implementing and evaluating an improved nutritional support, using digital communication and registration tools during the clinical pathway. The project targets a group of patients with a high frequency of malnutrition, due to cancer and the subsequent therapy, where knowledge on the efficient and cost-effective treatment is scarce. The effect of the improved nutrition support will be evaluated in a randomised controlled trial, and the primary endpoint is the prevalence of malnutrition. The long-term goal is to benefit the patients by increasing the completion rate of cancer treatment, reducing the infection rate, need for antibiotics, the total length of hospital stays and number of non-elective re-admissions, and thus increasing the patients' quality of life and survival. The project will be patient-orientated and result in a sustainable approach for the management of malnutrition.

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: NCT05532306 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition

Start date: October 11, 2020
Phase: Phase 1
Study type: Interventional

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Ribavirin 400 mg, after administering a single oral dose, to healthy adult subjects under fed conditions.

NCT ID: NCT05527522 Completed - Heart Failure Clinical Trials

Nutritional Intervention in Malnourished Patients With Chronic Heart Failure

PACMAN-HF
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Malnutrition is common in patients with heart failure (HF) and is associated with a worse prognosis. However, there is little information on the impact of nutritional intervention in malnourished patients with heart failure. Therefore, the aim of our study is to evaluate whether a specific nutritional intervention has an impact on mortality and hospitalizations, quality of life, nutritional status, and functional capacity in patient with heart failure and malnutrition.

NCT ID: NCT05525429 Not yet recruiting - Undernutrition Clinical Trials

Enhancing Milk Consumption by Vulnerable Household Members in Rural Nepal

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

Diet quality is generally poor in rural Nepal, especially among vulnerable household members. Consumption of milk (and other animal source foods [ASF]) could contribute to improvements in diet quality. However, multiple cultural, structural and economic barriers constrain the inclusion of ASF in the diet in these households, even though most raise dairy animals. This study will 1. characterize these barriers in detail 2. conduct a randomized controlled trial to test a multi-dimensional behavior change intervention designed to increase ASF/milk consumption by young children 6-60 months, adolescent girls 10-15 years, and women of child-bearing age (WCBA). Matched clusters of villages in Kapilbastu and Nawalparasi districts (Nepal) will be randomized to Intervention or Control status. Household surveys will be conducted at baseline and 12 months later to collect demographic, diet, feeding practices, nutrition knowledge, etc. Fathers and adolescent girls will respond to mini-surveys. Growth parameters of children, adolescent girls, and WCBA will be assessed. The intervention consists of 4 components: 1) didactic training (mothers, fathers, adolescent girls), 2) participatory learning activities (mothers, fathers, adolescent girls), 3) model kitchens (mothers, adolescent girls), and 4) Nutrition Club (adolescent girls). The primary outcome will be the impact of the intervention on diet, household feeding practices, and nutrition knowledge.

NCT ID: NCT05520879 Not yet recruiting - Malnutrition Severe Clinical Trials

Effectiveness Trial of Locally Developed Ready to Use Therapeutic Food

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

As poor health conditions and malnutrition are major issues confronting the influx of Forcibly Displaced Myanmar Nationals (FDMN), there is an urgent need to prepare the service providers to control the situation and to prevent deaths and disabilities in FDMN children suffering from severe acute malnutrition (SAM). It is therefore imperative to assess the effectiveness of the two local Nutrition Managements (NMs); Sharnali 1 & Sharnali 2 for the treatment of SAM in an emergency in Bangladesh. If the effectiveness trial shows that the NMs are effective, either one or both varieties can be used for children with SAM in emergency situations. Ultimately a Bangladeshi solution will replace the expensive RUTF that is currently being imported for use in the FDMN camps for management of SAM.

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: NCT05517395 Completed - Stunting Clinical Trials

The Effectiveness of HBM-based Education Program on Improve Knowledge and Behaviors

Start date: September 10, 2022
Phase: N/A
Study type: Interventional

The randomized controlled trial design with one intervention arm (nutrition education and complementary feeding) and one control (usual care) arm (1:1 ratio). Randomization of each participant to the groups will be carried out using Random Allocation Software 1.0 (https://random-allocation-oftware.software.informer.com/1.0/) to intervention or control groups in a 1:1 ratio. The sample size to be recruited is 80 participants.

NCT ID: NCT05513651 Active, not recruiting - Malnutrition Clinical Trials

Establishment of a Model for Predicting the Prognosis of HBV-related Decompensated Liver Cirrhosis Based on RFH-NPT

Start date: July 1, 2016
Phase:
Study type: Observational

For all countries, chronic liver disease and liver cirrhosis is one of the important disease burdens. Malnutrition is an important complication of liver cirrhosis, which always runs through the course of liver cirrhosis. According to a lot of scientific research evidence, as the consensus of experts all over the world, malnutrition in patients with liver cirrhosis is closely related to poor outcome. Therefore, early and accurate identification of the risk of malnutrition is very important to improve the prognosis of patients with liver cirrhosis. The purpose of this study was to study the relationship between malnutrition-related indexes and prognosis in patients with liver cirrhosis. 2000 patients with liver cirrhosis were prospectively included, laboratory indexes related to malnutrition and other evaluation indexes were recorded, and long-term follow-up was made to observe the short-term and long-term prognosis of patients with liver cirrhosis. At the same time, a prognostic prediction model was established based on multivariate Cox regression, and a series of in-depth studies and verification were carried out on this basis.

NCT ID: NCT05512975 Not yet recruiting - Clinical trials for Protein-Energy Malnutrition

FortiPhy: Protein Bioavailability, Satiety and Appetite

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

Older adults have very specific food and nutrient requirements and often struggle to meet these needs due to poor appetite, reduced functionality and dexterity. Protein (both quality and quantity) is an important macronutrient in maintaining muscle in older adults which can help prevent falls, delay disease onset and help individuals maintain independence. Fortifying regular/ everyday foods with additional protein is one strategy to help older adults meet these increased protein needs. However, it is well established that protein is the most satiating of the nutrients we eat, yet less is known about how this is impacted by age and protein type. This study aims to test 2 protein fortified porridge recipes in older adults (and a control recipe) with outcomes focused on protein bioavailability, appetite and satiety responses.