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Malnutrition clinical trials

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NCT ID: NCT04202939 Recruiting - Malnutrition Clinical Trials

nutritionDay in Nursing Homes Worldwide: An International Audit and Registry on Nutrition and Outcome

Start date: February 2007
Phase:
Study type: Observational [Patient Registry]

Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional status. Deterioration of the health status and of nutritional intake is further associated with chronic malnutrition, impaired quality of life, increased morbidity, mortality and long-term care. In order to ensure optimal nutritional care of nursing home residents and therefore have a lasting positive affect on their quality of life, morbidity and mortality, it is necessary: - to collect data on the quality of nutritional care in nursing homes by means of a simple method that requires no specialization in data acquisition, - to acquire knowledge on the prevalence of risk factors of malnutrition in nursing home residents in general and on individual nursing units, also in conjunction with the outcome after six months, and to forward the same to the individual nursing units, - to allow comparison with other facilities (with similar profile) with the help of a benchmarking system, - to assess the effectiveness of introduced changes in terms of quality management and quality improvement.

NCT ID: NCT04190121 Recruiting - Esophageal Cancer Clinical Trials

Perioperative Nutritional Support in Esophageal Cancer Patients

NEEC
Start date: March 26, 2019
Phase: N/A
Study type: Interventional

Upper GI malignancies often lead to involuntary weight loss and nutritional deficits. Nutritional support, both pre- and postoperatively, may improve post-operative course and reduce length of hospital stay. This prospective randomized trial aims to investigate the above mentioned hypothesis and clarify any variants that may differ between the investigation and control group at a statistically significant level.

NCT ID: NCT04188990 Completed - Colorectal Cancer Clinical Trials

Cost Effectiveness of an Intervention in Hospitalized Patients With Disease-related Malnutrition

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

Objectives: To evaluate the effectiveness, and cost-effectiveness, of three hospitalized patient care strategies in relation to disease-related malnutrition (DRM) hospital admissions based on results such as length of stay of the index admission, and from admission until one year after admission, mortality rate, appearance of complications, changes in weight and nutritional state, changes in their health related quality of life and functional status, readmissions, use of health services resources (primary care, hospital and emergency consultations) and costs. Methodology: Intervention study involving three hospitals with three branches in which, after nutritional screening in all centers, the first branch / hospital includes a intervention strategy for nutritional improvement in patients who after screening are identified as having DRE or at risk of DRE, and follow-up of other patients; a second cohort / hospital will include similar patients in which if there is any nutritional intervention it will be carried out by demand of the medical staff in charge of the patient; and a third branch /hospital in which the usual practice of the center will be followed without any explicit intervention. Subjects of the study: At least 300 patients in each center admitted to the digestive services, due to digestive pathologies, and surgery services due to tumor and digestive system pathologies. In all patients, sociodemographic and clinical data will be collected and of the outcomes described above during admission and until the year of follow-up. Statistical analysis: through appropriate multiple regression models for each outcome variable and with adjustments through propensity scores to compare the three centers based on each outcome parameter. A cost-effectiveness analysis will be carried out through of the incremental cost for each year of quality-adjusted life (QALY) .

NCT ID: NCT04185597 Completed - Stunting Clinical Trials

Bangladesh MSNP: Agricultural/Livelihood Mixed Methods Study

HFP MSNP
Start date: July 7, 2018
Phase: N/A
Study type: Interventional

Despite progress in reducing high levels of undernutrition in Bangladesh, gaps in progress persist. They are particularly acute between rural and urban areas, and between the lowest wealth quintile and highest. According to the 2016 Bangladesh DHS report, 38% of rural children under five were stunted compared to 31% of urban children. Forty-nine percent of children in the lowest wealth quintile were stunted compared to 19% in the highest. To address these discrepancies and lower the overall level of stunting, research is being conducted to assist the government of Bangladesh (GoB) in determining the most effective ways to reduce levels of stunting. In particular, positive correlations between household production and consumption of nutritious food have been widely documented by development organizations in Bangladesh. However, information on how to optimize the delivery of household food production programs is needed. The primary objective of this study is to compare the effectiveness of current standard practice with two multisectoral intervention packages focused on homestead food production: 1. Homestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services 2. HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services The study's primary outcome is the percentage of children 6-23 months old receiving a minimum acceptable diet (MAD), as a proximate determinant for stunting. MAD is defined as the proportion of children 6-23 months old who receive both the minimum feeding frequency and minimum dietary diversity for their age group and breastfeeding status. It will be assessed based on the mother/caregiver report. Secondary outcomes include assessing the knowledge, attitudes, and practices around breastfeeding, complementary feeding, water sanitation and hygiene, health services and gender norms. Quantitative surveys, in depth interviews, focus group discussions, report reviews and process documentation will be used to assess intervention strengths, weakness, and cost effectiveness.

NCT ID: NCT04185571 Recruiting - ESRD Clinical Trials

Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis

NutriPEPA2
Start date: July 12, 2011
Phase: N/A
Study type: Interventional

NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or HDF-treated stage 5 renal failure compared to a non-adsorbent synthetic membrane.

NCT ID: NCT04184713 Completed - Cancer Clinical Trials

Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition

NCT ID: NCT04183075 Not yet recruiting - Malnutrition Clinical Trials

Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture

IRENE
Start date: September 2020
Phase: N/A
Study type: Interventional

Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture.

NCT ID: NCT04174846 Withdrawn - Clinical trials for Severe Acute Malnutrition

Comparison of Treatment of SAM in Children 6-59 Months With RUTF and RUSF in Umerkot, Sindh, Pakistan

Start date: January 2021
Phase: N/A
Study type: Interventional

In Pakistan, around 15% of children under five are wasted, which is almost twice that of the global prevalence 7.5%. There is a demand for a reliable and consistent locally available severe acute malnutrition (SAM) treatment option since currently the only option is to use an imported ready-to-use-therapeutic food (RUTF). While imported RUTF is successful for treatment of children with SAM, Pakistan is often faced with supply chain issues and consequentially management of SAM with RUTF is unreliable. The World Food Programme (WFP)'s work in Pakistan supports government-led efforts to improve food and nutrition security, including the development of Acha Mum, a chickpea containing lipid-based ready-to-use-food. Acha Mum replaces the peanut in standard RUTF formulation with chickpea, a locally available legume. Acha Mum is well accepted by children in Pakistan and is currently being used as a treatment for children with moderate acute malnutrition (MAM) in targeted supplementary feeding programs (TSFP) throughout the country. The broad objective of this clinical trial is to test the effectiveness of a chickpea-based specialized nutritious food Acha Mum, compared to a standard RUTF for the treatment of SAM. The study will be conducted in 10 basic health units (BHUs) operating by PPHI in Umerkot district of Sindh, Pakistan. This will be an individual randomized, double-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods. A total of 1700 children will be part of the study (850 children in RUTF and 850 children in Acha Mum group). Children aged 6-59 months with SAM, i.e. MUAC <11.5 cm and/or with bilateral pitting oedema (+, ++), with appetite and without medical complications presenting at selected rural therapeutic feeding clinics. The primary outcome is recovery from SAM, defined as: MUAC ≥ 11.5cm (for two consecutive weekly visits), clinically well, no bilateral pitting oedema (for two consecutive weekly visits). The secondary outcomes include neurocognitive performance after first 4 weeks of treatment as assessed by eye tracking and infant problem solving; changes in MUAC, weight, and length; time to recovery from SAM; time to recovery from MAM defined as achieved a MUAC ≥12.5 cm; relapse into MAM; relapse into SAM and any adverse events.

NCT ID: NCT04171388 Withdrawn - Preterm Birth Clinical Trials

Enhancing Nutrition and Antenatal Infection Treatment for Maternal and Child Health in Ethiopia

ENAT
Start date: March 1, 2020
Phase: Phase 4
Study type: Interventional

The ENAT study will test the impact of packages of antenatal interventions to enhance maternal nutrition and manage pregnancy infections on the outcomes of infant birth size, gestational length, and infant growth in the first 6 months of life. Approximately 5,280 pregnant women will be enrolled into the study from 12 health centers in the Amhara region of Ethiopia. Routine antenatal care will be strengthened in all health centers, and six health centers will be randomized to additionally provide a nutritional intervention including daily multiple-micronutrient or a fortified balanced-energy protein supplement for malnourished women. Women across all 12 health centers will be individually randomized to receive one of three infection management interventions in pregnancy: 1) enhanced infection management package (screening-treatment for urinary tract infections and sexually transmitted infections, presumptive deworming); 2) presumptive azithromycin (2g at <24 wks and a second dose at least 4 weeks later); or 3) placebo. The women and their infants will be followed until 6 months postpartum. Outcomes of interest include birth size (weight, length), gestational age, maternal weight gain in pregnancy, maternal anemia, antimicrobial resistance, and infant size at 6 months.

NCT ID: NCT04168814 Completed - Quality of Life Clinical Trials

Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients in Spain: the NutriOncoSearch (NOS) Study

NOS
Start date: June 10, 2020
Phase:
Study type: Observational

Malnutrition is a common medical problem in oncology patients. It is well known that the presence of malnutrition negatively affects patients' evolution and their quality of life, increasing the incidence of infection, hospital stay, and mortality. The new knowledge of cancer biology has made it possible to know the mechanisms of cancer progression. New treatments have been developed thanks to this knowledge including molecular target treatments aimed at these cancer mechanics and to reverse the antitumor capacity of the immune system. However, these treatments have different toxicities than classic and anachronistic treatments such as chemotherapy and radiotherapy, including alterations in glucose metabolism, endocrinopathies, rhabdomyolysis, etc. that can alter both the patient's nutritional status and quality of life. Additionally, a deficient nutritional status can have an impact on the intestinal microbiota, compromising the efficacy of the new antitumor treatments. The principal objective of this study is to characterize the nutritional status of the cancer outpatient receiving immunotherapy through a screening performed in Hospital consultations in Spain. Secondary Endpoints are (a). To describe the percentage of patients that receive nutritional counseling or nutritional support (enteral and/or parenteral nutrition) among those diagnosed as malnourished or at risk. And (b) to categorize the percentage and descriptive characteristics of cancer patients with mild, moderate, or severe malnutrition that goes to a hospital consultation in Spain and describe the percentage and descriptive characteristics of patients with malnutrition according to sociodemographic and clinical characteristics.