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Malnutrition clinical trials

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NCT ID: NCT02820246 Recruiting - Malnutrition Clinical Trials

NutritionDay in Worldwide Hospitals: An International Audit and Registry on Nutrition and Outcome

nutritionday
Start date: January 2006
Phase:
Study type: Observational [Patient Registry]

Malnutrition at hospital admission is a risk factor for an unfavourable outcome, prolonged hospital stay and delayed recovery. In these patients the incidence of complications such as nosocomial infections, poor ventilatory function, prolonged bed rest is increased. In addition a relevant proportion of patients have a nutritional intake below their needs during hospitalisation.Mortality has been shown to be up to 8 times higher and dependency at discharge up to 3 times more frequent when actual food intake was below 25% of calculated needs. The aim of this international cross-sectional multicentre audit and registry is to generate a risk and level of nutritional intervention profile for an individual unit/ward based on case-mix, nutrition care and available structures. This profile should give a snapshot on the relation of risk to resource allocation. The audit is unit centered. Each unit gets as a feedback anonymously its position compared with all other participating units. Risk adjustment for selected patient groups, social environments and structures is planned. In conclusion this audit/registry will serve five distinct aims: - Generate a precise map of the prevalence of malnutrition before admission and of decreased nutrient intake according to risk factors, medical specialty, organisational structures and countries. - Increase in awareness for clinical nutrition in patients, caregiver and hospital managers. - Enlarge and maintain a reference database for hospitalised patients - Provide individual unit benchmarking

NCT ID: NCT02812615 Recruiting - Malnutrition Clinical Trials

The Bangladesh Environmental Enteric Dysfunction Study

BEED
Start date: July 16, 2016
Phase: N/A
Study type: Interventional

This is a community-based intervention study which will be undertaken at Mirpur, Dhaka, Bangladesh. Participants will be recruited from two age groups: a child cohort (age 12 to 18 months) and an adult cohort (age 18 to 45 years). The child cohort will consist of stunted children (length for age Z score, LAZ < -2), children who are at risk of stunting (length for age Z score <-1 to -2) and child controls. The adult cohort will consist of malnourished adult cases (Body Mass Index <18.5) and adult controls. After screening the participants for any organic diseases and application of inclusion/exclusion criteria, they will receive nutrition interventions. Participants eligible for study will be tested for potential bio markers of environmental enteropathy (stool, urine and serum) once before and once after the nutritional intervention. Participants who will fail to respond to nutritional therapy (measured by anthropometric assessment) will become candidates for upper gastrointestinal endoscopy with biopsy. The study will include duodenal biopsies from a control group of children from University of Virginia Hospital in Charlottesville, Virginia who will undergo upper GI endoscopy as part of their clinical care as per the standard clinical protocol followed at the hospital. Adult controls (BMI > 18.5) for endoscopy will be collected from international centre for diarrhoeal disease research,Bangladesh staff clinic, Dhaka Medical College and Hospital (DMCH), Dhaka and Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka.

NCT ID: NCT02812134 Recruiting - Malnutrition Clinical Trials

Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.

IPSAASU
Start date: June 2015
Phase:
Study type: Observational

Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced by osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action and inhibition of 1,25-OH vitamin D). There are no published studies on the role of FGF23 in undernourished anorexic adolescents taking oral phosphorus supplements.

NCT ID: NCT02683720 Recruiting - Malnutrition Clinical Trials

Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly

ProMO
Start date: July 2016
Phase: N/A
Study type: Interventional

ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.

NCT ID: NCT02669654 Recruiting - Pneumonia Childhood Clinical Trials

Effectiveness Trial of Day-care vs. Usual Care of Severe Pneumonia & Malnutrition in Children

Day-care
Start date: November 1, 2015
Phase: Phase 4
Study type: Interventional

Background: At present pneumonia and malnutrition have become the leading causes of mortality among <5-year-old children in developing countries. World Health Organization standard management of severe pneumonia and severe malnutrition requires hospitalization for supportive care. As many developing countries including Bangladesh do not have enough pediatric hospital beds to accommodate the demand for admission of all children with severe pneumonia and malnutrition, Investigators developed alternative treatment option such as "Day Care Approach", for those children who cannot be hospitalized, but are too sick to be managed in the community. After successful Day Care Approach of management of efficacy trials with severe childhood pneumonia and severe malnutrition, the next step is to conduct an effectiveness trial under "real life" condition, i.e. within the Health Systems of Bangladesh. Burden: Pneumonia is the leading cause of mortality in developing countries, being responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing countries. Similarly, malnutrition is a major health problem with an estimated 1.7 & 3.6 million children dying annually because of Severe Acute Malnutrition & Moderate Acute Malnutrition, respectively. Objectives: To assess & implement the Day Care Approach of management of severe childhood pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into existing Health Systems of Bangladesh as a safe & cost effective alternative to Existing Treatment. Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving 16 clusters (Wards) in Dhaka & 16 clusters (Unions) in rural areas that will be randomly assigned to intervention & control arm. Children with severe pneumonia will be enrolled in (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day care Approach in intervention clusters by involving Comprehensive Reproductive Health Centres in urban and Health and Family Welfare Centres in rural areas. Outcome variables: - Primary: clinical treatment failure by day 6 - Secondary: (i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost effectiveness (iii) Referrals to hospitals (iv) Deaths

NCT ID: NCT02440165 Recruiting - Malnutrition Clinical Trials

Basic Care Revisited: Early Nutrition Intervention for Outpatients

BCR_N
Start date: January 2015
Phase: N/A
Study type: Interventional

Early nursing nutrition intervention for outpatients in need of surgery - Objective - To investigate the feasibility and effectiveness of screening and an early nursing intervention on malnutrition in outpatients in need for surgery. - Design - Multi-centre cluster-randomised controlled early trial design (n=150 patients) - Intervention - Malnutrition screening (during outpatient clinic visit) and (in case of patients being ´at risk for malnutrition´ or being ´malnourished´), a nutrition care plan (including nutritional drinks and energy and protein rich meals) tailored to individual patient requirements - Comparison - Usual care (no nutritional care plan)

NCT ID: NCT02418065 Recruiting - Clinical trials for Chronic Kidney Failure

Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

AMERICANO
Start date: December 2013
Phase: Phase 3
Study type: Interventional

The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.

NCT ID: NCT02404987 Recruiting - Malnutrition Clinical Trials

An Oral Nutritional Supplement Study in Older Malnourished Spanish Population

Start date: June 2014
Phase: N/A
Study type: Observational

Post-marketing observational study of a nutritional care plan, including a higher calorie, higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished. The objective is to assess the impact of the ONS on body weight, activities of daily living and quality of life.

NCT ID: NCT02275676 Recruiting - Malnutrition Clinical Trials

Resting Energy Expenditure and Nutritional Status in IBD

CEDERN-1
Start date: September 2014
Phase: N/A
Study type: Observational

Nutrient deficiencies occur frequently in IBD patients. The absorption rate of nutrients in IBD is often limited by chronic inflammation, but is also commonly reduced by missing intestinal segments due to previous operations. Patients are predominantly affected by malnutrition, which is often resembled by weight loss, specific micronutrient deficits such as iron deficiency, vitamin B12 deficiency, folic acid deficiency, vitamin D deficiency and zinc depletion. The etiology of nutritional problems is multifactorial and not exclusively limited to active phases of the disease. Causes of malnutrition can be inadequate food intake, maldigestion, malabsorption or increased nutritional requirement. Malnutrition itself is associated with a delayed recovery of impaired wound healing, reduced quality of life and longer hospital stays. Therefore, observation and modification of the nutritional status should be an integral part of therapy in IBD patients. The primary objective of our study is to investigate the influence of the disease on the resting energy expenditure and nutritional status during acute inflammation and clinical remission of the disease. Secondary objectives are to assess possible nutritional deficiencies. On the other hand it is well known that patients with IBD are at increased risk for coronary heart disease. Therefore, another secondary focus of our observational study is whether the composition of the HDL proteins is changed towards pro-atherogenic HDL-proteins and whether possible changes occur in patients in clinical remission or with active disease.

NCT ID: NCT02249754 Recruiting - Malnutrition Clinical Trials

Nutrition Education Package for Infants and Young Child Feeding and Health in Rural Tanzania

NECTAc
Start date: September 2014
Phase: N/A
Study type: Interventional

Building on the success of community-based peer education and counselling in breastfeeding, it is possible to address young child feeding and health practices in the surveyed district. Opportunities that can optimise success and encourage behaviour change in the district include mothers willingness to modify some feeding options; support of family members; seasonal availability and accessibility of foods; established set-up of village peers and existence of health centres and health staff in some villages. This study has developed a feasible, context-specific nutrition education package for use in rural Tanzania. The package is composed of 4 components, namely 1) education and counselling of mothers, 2) training of community-based nutrition counsellors, 3) sensitisation meetings with health staff and family members, and 4) supervision of community-based nutrition counsellors. The intervention will use a parallel cluster-randomised controlled trial design where infants will be recruited when aged 6 months and followed up for 9 months. The intervention expects to provide information and, where appropriate, recommendations to strengthen the nutrition component in the health education programme of the Tanzania child health services. The study hypothesises that the nutrition education package will be more effective than the routine health education in improving feeding practices, dietary adequacy and growth of infants and young children. Specific objectives of the study include: - To evaluate the effectiveness of a nutrition education package on feeding practices and dietary adequacy - To determine the effectiveness of a nutrition education package in improving growth and health of infants and young children - To document the process of implementation of the nutrition education package to promote optimal feeding and health practice