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Malnutrition clinical trials

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NCT ID: NCT02872493 Active, not recruiting - Obesity Clinical Trials

Small Bowel Length and Bariatric Surgery Outcomes

Start date: August 2016
Phase:
Study type: Observational

The purpose of this study is to determine whether or not the total length of small intestine effects outcomes after bariatric surgery in a cohort of patients preoperatively and up to ten years postoperatively. Roux-en-Y gastric bypass and vertical sleeve gastrectomy will be the surgical groups in this study. We aim to determine if bowel length has a significant effect on long term weight loss or other nutritional deficiencies in this bariatric cohort.

NCT ID: NCT02775721 Active, not recruiting - Malnutrition Clinical Trials

Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement

G-Tube
Start date: July 2015
Phase: N/A
Study type: Interventional

Poor nutritional status and malnutrition are prevalent for patients undergoing treatment for head and neck cancer. Inadequate dietary intake is multi factorial, with patients experiencing dysphagia and or anorexia caused by various cancer treatments. Current standard practice utilizes Gastrostomy Tube placement to manage adverse nutritional effects related to Head and Neck cancer treatment.

NCT ID: NCT02751476 Active, not recruiting - Marasmus Clinical Trials

Effectiveness of Safe Drinking Water in Treatment of Severe Acute Malnutrition (Pakistan)

Start date: April 2016
Phase: N/A
Study type: Interventional

This study builds evidence on the importance of using safe drinking water during the nutritional treatment of children affected by Severe Acute Malnutrition (SAM). The following hypotheses will be tested: 1.The addition of safe drinking water to SAM treatment will reduce exposure to pathogens that cause diarrhoeal disease, thereby reducing diarrhoea incidence among enrolled children. 2.Reductions in pathogen exposure and diarrhoeal disease will result in shorter recovery pe-riods for children with SAM. The study will evaluate the effectiveness of safe drinking water in reducing SAM treatment cost and duration and will provide recommendations for improving SAM treatment protocols.

NCT ID: NCT02746276 Active, not recruiting - Malnutrition Clinical Trials

Optimising Antibiotic Treatment for Sick Malnourished Children

FLACSAM-PK
Start date: April 1, 2016
Phase: Phase 2
Study type: Interventional

Children with severe malnutrition who are admitted sick to hospitals have a high mortality, usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics. However, policymakers are not sure that the current antibiotics are the most effective. It is possible that the antibiotics that are currently used as second-line should be used first. Finding this out will need a large trial comparing different antibiotics. To prepare for such a trial the investigators first want to make sure that the doses given are correct for malnourished children. The investigators also want to check whether malnourished children more commonly carry resistant bacteria in their feces than well-nourished children. The study is important because the types of antibiotics and the doses needed to fight infection may be different in malnourished children because of the changes in their body due to malnutrition and the types of bacteria present.

NCT ID: NCT02540252 Active, not recruiting - Inflammation Clinical Trials

Nutrition and Inflammation Among Patients With Lower Limb Amputation

Amp-Nu
Start date: August 19, 2015
Phase: N/A
Study type: Observational

Patients with non-traumatic lower limb amputation are characterized by; high age; majority being men; multimorbidity; and high mortality. The patients comorbidities are related to diabetes and cardiovascular disorders such as arteriosclerosis. Major surgery induces a surgical stress response that initiates a catabolic metabolism. Furthermore, the risk of systemic inflammatory response syndrome (SIRS) both before and after amputation is high (3) as the most prominent indication for amputation is gangrene, followed by non-healing or infected wounds. This leads to an impaired immune response and an increased insulin resistance that also includes a cascade of impaired appetite regulation, low dietary intake and reduced nutrient uptake form the intestine which increases inflammation, loss of muscle and risk of severe complications. Among healthy adults with a normal weight a slow speed of eating will result in a low nutritional intake due to faster satiety experience. Low appetite following major surgery is related to the regulation of hormone controlling the appetite. Especially older patients experience variations in appetite that affect their eating pattern such as eating speed and intake. It is therefore reasonable to assume that the speed of eating and the total nutritional intake among older patients, who are exposed to catabolic metabolism, are associated. The hypothesis is that major surgery induces a change in patients' current eating pattern that is measurable and can be identified as a surrogate measurement of the catabolic state that is related to inflammation. Eating Patterns are often described in clinical practice without engaging in nutritional assessment of the patient. Whether the speed of eating is an objective marker of the current nutritional status has not been established. This study investigates patients undergoing lower limb amputation and their nutritional status, eating pattern and inflammation and whether this is linked to the current degree of disease. The purpose is to describe the development in nutritional status before and after amputation and to investigate associations between patients eating pattern and nutritional status to inflammatory and metabolic biomarkers reflecting the degree of disease.

NCT ID: NCT02463565 Active, not recruiting - Undernutrition Clinical Trials

Assessment of Food Intake in Hospitalized Patients

UN+
Start date: September 1998
Phase: N/A
Study type: Observational

Food provision and consumption were assessed for all hospitalized patients over a 24h-period survey. This study is a part of a control quality programme and is performed every 4 years since 1999.

NCT ID: NCT02457923 Active, not recruiting - Under Nutrition Clinical Trials

Mobile -Solutions Aiding Knowledge for Health Improvement

M-SAKHI
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Using a community-based, cluster randomized controlled trial design (cRCT) the investigators will examine the impact of an integrated "m-health package -(M- SAKHI) for mothers on appropriate infant feeding practices, starting in the first / second trimester of pregnancy to 24 months after delivery, to improve child feeding practices and child growth, and reduce the prevalence of undernutrition in their children. This will result in two treatment groups. The clusters for the trial will be villages under the administrative area of ASHAs (Accreditated Social Health Activists). Villages with a population of 1000- 2000 (ranging from 751 to 2000) with 1 ASHA will be randomized to receive intervention (intervention villages) or continue existing delivery of care (control villages). The data will be collected using a longitudinal design because the investigators want to study the impact of intervention on the mothers starting at pregnancy until her infant is 24 month old.

NCT ID: NCT02441426 Active, not recruiting - Malnutrition Clinical Trials

Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development

MAL-ED
Start date: November 2008
Phase: N/A
Study type: Observational

Malnutrition is considered one of the most prevalent risk factors for morbidity and mortality in children under five. An estimated 20% of children in the developing world are malnourished [1] and poor nutrition is linked to more than half of all child deaths worldwide [2]. Malnutrition in early childhood may lead to cognitive and physical deficits and may cause similar deficits in future generations as malnourished mothers give birth to low birth weight children [3]. In addition, malnutrition increases susceptibility and incidence of infections and is associated with diminished response to vaccines. The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that alter gut function and impair children's nutrition, growth and development to help develop new intervention strategies that can break the vicious enteric infection-malnutrition cycle and reduce its global burden. The overall objective of the MAL-ED Project is to quantify the associations of specific enteric pathogens, measures of physical and mental development, micronutrient malnutrition, gut function biomarkers, the gut microbiome, and immune responses in very young children in resource-limited settings across eight sites that vary by culture, economics, geography, and climate. The central hypothesis of the MAL-ED Project is that infection (and co-infection) with specific enteropathogens leads to impaired growth and development and to diminished immune response to orally administered vaccines by causing intestinal inflammation and/or by altering intestinal barrier and absorptive function. Data analyses will test for associations between enteropathogen infections and growth/development to help illuminate: - which micro-organisms or mixed infections are most frequently associated with growth faltering and poor development; and - at what age specific infections cause the most disruption to growth and development and impair immune response.

NCT ID: NCT02414399 Active, not recruiting - Malaria Clinical Trials

Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children

Toto Bora
Start date: June 28, 2016
Phase: Phase 4
Study type: Interventional

Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity and mortality following discharge from hospital. These children represent an accessible high-risk population in which targeted interventions to prevent morbidity and mortality could have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated an almost 50% mortality benefit in children 1-9 years of age in treated communities. However, mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance within treated communities and is expensive. The targeted delivery of azithromycin to children at hospital discharge may be a novel and practical intervention to maximize benefit while minimizing risk of antibiotic resistance. This is a randomized, double-blind, placebo-controlled trial to determine the efficacy of azithromycin provided at discharge, compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59 months in Kenya. The study will also investigate potential mechanisms by which azithromycin may reduce morbidity and mortality in this population and will assess the emergence of antibiotic resistance among treated individuals and their primary caregivers. A cost-effectiveness analysis of the intervention will also be conducted.

NCT ID: NCT02272842 Active, not recruiting - Malnutrition Clinical Trials

Vitamin B12, Neurodevelopment and Growth in Nepal

BeLive
Start date: April 20, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of Vitamin B12 is animal-source foods. Vitamin B12 is crucial for normal cell division and is necessary for brain growth as well as for the maintenance of its normal function. Deficiency is also associated with impaired growth. In a previous study, we demonstrated that vitamin B12 administration over a period of six months enhanced growth, and scores on a neuro-developmental test in young Indian children. However, the overall effect was small and, for the developmental scores significant only in those that were malnourished at the start of the study. Our findings need to be verified in trials targeting younger, malnourished children and with longer supplementation time. Hypothesis: This proposed study will test three hypotheses; to measure to what extent 2 recommended daily allowances (RDA) of vitamin B12 administration for one year to stunted children improves; 1) growth, 2) neurodevelopment, and 3) hemoglobin concentration. Study design: Randomized placebo-controlled trial. Half of the children will receive a paste containing vitamin B12, the other half the same paste but without vitamin B12. Study participants and site: 600 malnourished infants in Bhaktapur municipality in Nepal. In this population we have demonstrated that vitamin B12 deficiency and poor growth is common in early childhood. Intervention: Daily administration of a paste containing vitamin B12 or placebo for 12 months Data: The main outcomes of this study are scores on developmental assessments tools and growth measured every month for 12 months.