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Malnutrition clinical trials

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NCT ID: NCT01641770 Completed - Malnutrition Clinical Trials

Oral Nutritional Supplementation in Hospital Patients

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS) plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.

NCT ID: NCT01634009 Completed - Clinical trials for Severe Acute Malnutrition

Soy-Ready to Use Therapeutic Food (RUTF) in Severely Malnourished Children

Start date: July 2012
Phase: Phase 2/Phase 3
Study type: Interventional

SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional edema is an important cause of death in children globally including Bangladesh. The death rate among children hospitalized for SAM is still high. Severe malnutrition in children can be successfully treated by using WHO guidelines with or without minor modification. Since the Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the treatment of children with SAM has gained ground, and huge amounts of RUTF are used particularly in African countries. RUTFs are an energy-dense lipid paste enriched with vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%. Although the CTC model promises treatment of SAM at a considerably lower cost than the previous inpatient model, the cost of RUTF is still considered a significant barrier to universal roll-out of SAM treatment and has made CTC implementation too expensive in many high-need countries. The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy protein has a cost per kg protein that normally is below that of skim or whole milk powder, and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high quality, complete protein that meets the daily protein requirements of growing children and adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of 1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed as the sole protein source at minimum recommended intake levels. To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked intervention trial 300 SAM children aged 6 to 59 months after completion of their stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at the outpatient department of this Dhaka Hospital of icddr,b.

NCT ID: NCT01632072 Completed - Weight Loss Clinical Trials

The Undernourished Patient: Prevention and Treatment

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether a nutrition intervention during a rehabilitation stay followed by nutritional advice after discharge, can improve the nutritional status of the patients after 3 months.

NCT ID: NCT01627496 Completed - Malnutrition Clinical Trials

Nutritional Status and Quality of Life in Older Adults

NSQLOP
Start date: September 2010
Phase: N/A
Study type: Observational

The aim of this study is to determine the nutritional status, and factors affecting malnutrition in older people staying in hospitals. Objectives: - To recruit a sample of older people in hospital - To collect information on nutritional status, satisfaction with food-related life and experience with access to food in hospital. - To assess the staffing attitudes to nutritional care of the older adult - To undertake an audit of therapeutic ('special') diets served in hospitals, with respect to their nutritional adequacy and wastage - To investigate predictors and correlates of malnutrition within the hospital setting and compare these relationships with those previously identified in care homes and the community. - To make recommendations for practice to improve the nutritional status of hospitalised older adults.

NCT ID: NCT01622036 Completed - Cancer Clinical Trials

Prevalence of Malnutrition in Oncology (PreMiO)

PreMiO
Start date: June 2012
Phase: N/A
Study type: Observational

It is estimated that up to 30% of cancer patients die because of the effects of malnutrition, caused by a discrepancy between nutritional needs and intake (or utilization) of energy and essential nutrients. Malnutrition and its severe complication, cancer cachexia, are negative prognostic factors in neoplastic patients, inducing Decreased response and tolerance to antineoplastic treatments, decline in the functional status, reduced quality of life and reduced survival. Prevalence data on malnutrition in italian oncology patients are lacking and the available literature data on weight loss and malnutrition in oncology refer to patients in different phases of disease and therapy. Most importantly , strategies for prevention of malnutrition and cachexia in oncology are still largely disregarded and scarcely implemented. The main objective of this project is to assess the prevalence of malnutrition in patients undergoing first medical oncology visit in Italy. Secondary objective is to increase awareness of metabolic and nutritional issues among medical oncologists, thus favoring the inclusion of metabolic-nutritional screening and monitoring in medical oncology protocols. This would in turn contribute to reduce the negative consequences of malnutrition- and cachexia-related complications.

NCT ID: NCT01613547 Completed - Clinical trials for Severe Acute Malnutrition

The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

Start date: October 2012
Phase: N/A
Study type: Interventional

This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.

NCT ID: NCT01593969 Completed - Clinical trials for Severe Acute Malnutrition

A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition

Njugu Plus
Start date: May 2012
Phase: Phase 2
Study type: Interventional

The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.

NCT ID: NCT01584310 Completed - Malnutrition Clinical Trials

Validation of the STAMP Screening Tool

STAMP2
Start date: October 2012
Phase: N/A
Study type: Interventional

Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. In addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. Studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. This risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. Improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. In Israel, nutritional screening in not conducted among children since there is no proper validated screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file. Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements. A statistical analysis to examine the validity of the STAMP Tool shall be carried out using the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi square test.

NCT ID: NCT01563575 Completed - Obesity Clinical Trials

WHO-HPH Recognition Project on Fast-Track Implementation of Clinical Health Promotion

RP
Start date: January 2012
Phase: N/A
Study type: Interventional

The project's background is the notion that patient centred clinical health promotion has been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO describes health promotion as a key dimension of quality in hospitals, and the organization has developed standards on the topic in order to help hospital management and staff members to assess and improve the quality of health care and thereby achieve better health for patients, staff, and community. Even so, however, health promotion is still a very implicit part of nearly all quality standards on hospitals. Moreover, assessing hospitals departments' health promotion performance is still quite an unexplored area. On this basis, this project will test a new recognition process that uses the relevant WHO-HPH tools and standards to assess performance, by way of explicit documentation and evaluation of clinical health promotion activity. The project is deigned as a RCT, with a control group that undergoes the recognition process immediately and a control group that continue usual clinical routine. Then, after one year, the control group also begins the recognition process (= delayed start), while the Intervention group (=immediate-start) continues with the recognition process. Doing this allows for a great array of measurements, and hopefully the project will then show whether the recognition process really benefits implementation of health promotion in hospitals and health services, and also, if this really generates better health gains for patients and staff. The outcome measurements will be frequency of health promotion services delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity to patients in need. Such services could for instance be motivational counselling and brief interventions, as well as intervention, rehabilitation and after treatment. Physical, mental, and social health status among patients and staff will be measured by short form (SF36).

NCT ID: NCT01563393 Completed - Malnutrition Clinical Trials

Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children

STAMP
Start date: May 2012
Phase: N/A
Study type: Interventional

Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic malnutrition caused by chronic diseases. We aimed to evaluate the use of the Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) among children admitted in a pediatric hospital, and assess its effect on medical staff's awareness to nutritional status and health outcomes at discharge.