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Malnutrition clinical trials

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NCT ID: NCT03926949 Recruiting - Surgery Clinical Trials

Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients

OPPortuNity
Start date: October 30, 2019
Phase: N/A
Study type: Interventional

Malnutrition is common in surgical patients. Many studies have shown a clear association between malnutrition and poor surgical outcomes. Parenteral nutrition (PN) is a nutrition intervention that is given by vein and can be safely provided to malnourished patients. It contains carbohydrates, fats, and protein just like you would normally in your diet. Pre-operative PN is able to improve outcomes in surgical patients. However, pre-operative PN has traditionally required hospital admission which results in increased length of stay, hospital cost, and hospital-acquired infection. Moreover, in hospital pre-operative PN may not be feasible or prioritized when access to inpatient surgery beds is limited. Outpatient PN provides the opportunity to solve this problem. The feasibility and impact of outpatient PN in malnourished patients undergoing major surgery have not previously been studied. This study aims to evaluate the feasibility of outpatient pre-operative PN and its effect on patient's outcomes.

NCT ID: NCT03926715 Recruiting - Cancer Clinical Trials

Prevalence of Malnutrition in Surgery

PROMIS
Start date: January 6, 2017
Phase:
Study type: Observational

Nutritional disorders are highly prevalent in gastrointestinal cancer patients undergoing surgery and have shown to contribute significantly in short, mid and long-term clinical outcome. Although increasing evidence and expert suggestions there is still inadequate awareness about the clinical relevance of nutritional and metabolic alterations in surgical oncologic patients.

NCT ID: NCT03901742 Recruiting - Clinical trials for Protein-Energy Malnutrition

Usefulness of Protein-enriched Infant Formula in Pediatric Intensive Care.

Start date: December 28, 2016
Phase: N/A
Study type: Interventional

A multicenter prospective randomized controlled trial (RCT) will be performed in three hospitals. Patients meeting inclusion criteria will be randomly allocated to one of three enteral feeding formula with different protein content. Blood and urine test, nitrogen balance assessment and energy expenditure testing by indirect calorimetry will be performed at the beginning of nutrition regimen and at 24 hours, 72 hours and 5-7 days after initiation. The sample size for this trial is estimated as 90 participants, with approximately 30 participants in each group. The data analysis will be by intention to treat. This RCT will provide new data about the amount of protein needed to improve levels of serum protein and nitrogen balance, surrogate of protein balance, in critically ill infants receiving enteral nutrition.

NCT ID: NCT03802942 Recruiting - Hypoglycemia Clinical Trials

Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments With Nutritional Care

MENU-DM
Start date: July 1, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective randomized study to evaluate the efficacy of nutritional intervention for the prevention of hypoglycemia among diabetes patients with low albumin level that are admitted to internal medicine units, regardless of the reason for admission. All patients suitable for participation in the study will be asked to participate and be randomized to the interventional arm or the control arm. After admission to the internal medicine unit, eligible patients will be asked to participate in the study. After signing an informed consent form, patients will be randomized to the treatment or control arms. For patients allocated to the treatment arm, the physician in charge will prescribe 2 portions of GlucernaTM per day as part of the treatment protocol. The nurse in charge of the patient (at either the morning or evening shifts) will make sure the patient is receiving and consuming the ONS. For every patient included in the interventional arm, 2 bottles of GlucernaTM will be supplied to the patient, one at 08:00 with the morning medications, and one at 16:00 with the evening medications. For clarification purposes, the GlucernaTM will be supplied on top of the designated meal plan, as "over-feeding". Evaluation of adequate ONS consumption will be performed 2-3 hours after the dispensing of the ONS (at 10:00-11:00 and 19:00-21:00), and the amount consumed will be documented. Patients in the control arm will receive no oral nutritional supplementation, and their caloric intake will be composed of the food supplied by the hospital. Other analysis will be considered usual care. Additional diet consultations as requested by the medical staff will constitute usual care, and the patient will continue the study. The duration of ONS treatment will be the entire length of hospital stay. Upon discharge, a recommendation to continue nutritional care will be added to the patients' discharge letters but no oral nutritional supplement (ONS) will be prescribed or dispensed. Following discharge, a 30-day follow-up call will be made to ascertain whether the patient is alive, whether the patient was re-admitted or re-hospitalized, and the usage of ONS prescribed by the family/general practitioner that was consumed after the hospital discharge.

NCT ID: NCT03792412 Recruiting - Malnutrition Clinical Trials

BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management

Start date: May 22, 2018
Phase: N/A
Study type: Interventional

There is a growing number of patients undergoing bariatric surgery requiring lifelong follow-up. BagEL (Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management) is a survey to evaluate a newly developed structured disease management program including nutrition and lifestyle management in primary care.

NCT ID: NCT03783104 Recruiting - Child Malnutrition Clinical Trials

Maternal B12 Supplementation to Improve Infant B12 Deficiency and Neurodevelopment

MATCOBIND
Start date: April 27, 2019
Phase: N/A
Study type: Interventional

Vitamin B12 plays a key role in the development and normal functioning of the brain and nervous system. Unborn and new-born infants derive their vitamin B12 stores almost entirely from maternal B12 stores. As such, infants who are born to vegetarian mothers and exclusively breast fed are at a high-risk of B12 deficiency. This is because the best sources of vitamin B12 are found in animal based or fortified foods (e.g. cheese, milk and eggs). Vitamin B12 deficiency is widely reported among antenatal mothers and children, particularly in Low and Middle Income Countries (LMICs) where these food sources are uncommon. So far, studies have shown that antenatal vitamin B12 deficiency in mothers may be associated with poorer neurodevelopment in their children. Furthermore, vitamin B12 supplementation during pregnancy and early lactation has been shown to increase maternal, breast milk, and infant levels of vitamin B12. Although existing literature documents several studies on maternal vitamin B12 supplementation, there is a lack of research on the causative effect of maternal vitamin B12 supplementation on infant development. This project, funded by the Medical Research Council (MRC), will undertake a multi-centric nutritional trial in Nepal and India, as these are two LMICs where high incidence of vitamin B12 deficiency is reported.

NCT ID: NCT03723460 Recruiting - Malnutrition Clinical Trials

Passive Dietary Intake Assessment Study

PDIAS
Start date: November 15, 2018
Phase:
Study type: Observational

Currently, there is no accurate measurement of dietary intake. All current methodologies of assessing dietary intake have inaccuracy rates of 30 -70%. Accurate assessment of dietary intake is critical in understanding individual and population nutritional status and monitoring the effectiveness of public health interventions to maintain nutritional health. Estimating dietary intake in low and middle-income countries (LMICs) is remarkably challenging, albeit the high presence of malnutrition and the critical need for evidence-based data to inform policies and programmes on nutrition and health. This study aims to develop and validate a low-cost and robust system for accurate measurement of an individual's dietary intake in households in LMICs. This innovative system passively recognises food, records intake, and estimates nutrient content of food. The system will be validated in field trials in Ghana and Kenya.

NCT ID: NCT03692234 Recruiting - Deficiency; Diet Clinical Trials

Homoarginine Supplementation in Patients After Stroke

HiS
Start date: August 22, 2018
Phase: N/A
Study type: Interventional

This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.

NCT ID: NCT03647436 Recruiting - Depression Clinical Trials

Incidence of Geriatric Syndromes Overlap

Start date: August 1, 2018
Phase:
Study type: Observational

The overlap of depression and delirium as geriatric syndromes present in elderly patients with hospital admission due to hip fracture has been previously studied. Nevertheless, the relationships between these two clinical processes and other geriatric syndromes, especially malnutrition, have not been studied. For this reason, a prospective cohort study has been designed to know the differences in the incidence of geriatric syndromes during hospital admission due to hip fracture in patients with and without risk of malnutrition.

NCT ID: NCT03641001 Recruiting - Feeding Behavior Clinical Trials

Nutrition Intervention Integrated With Food Voucher to Improve Child Growth and Feeding Practices

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Brief Summary: Background: The period from birth to two years of age is the "critical window" for the promotion of optimal growth, health, and development. Insufficient quantities and inadequate quality of complementary foods, poor child-feeding practices and high rates of infections have a detrimental impact on growth. Approximately one-third of children less than 5 years of age in developing countries are stunted, and large proportions are also deficient in one or more micronutrients. An estimated 6% or 6 hundred thousand under-5 deaths can be prevented by ensuring optimal complementary feeding (CF) only. Knowledge gap: Even though the importance of CF is established, children < 2y are being fed complementary foods with poor nutrient quality, particularly in resource poor countries like Bangladesh. Relevance: Approximately 36% under 5 children are stunted in Bangladesh. Only 23% of children age 6-23 months is fed appropriately based on recommended infant and young child feeding (IYCF) practices. The routine diet of the population including children is mainly plant based and lacks adequate protein and other essential nutrients. Hygiene is also an issue as only 21% of rural households use soap and water during handwashing. An intervention package including CF counselling, WASH and micronutrient powder (MNP) could be potential option for optimizing complementary feeding practice in rural Bangladesh. Hypothesis: An integrated intervention package will improve child growth in terms of length and complementary feeding practice in the selected intervention area from rural Bangladesh compared to control area. Objectives: 1. To improve nutritional status (length for age Z-score or LAZ) of the children (6-12 mo) through food voucher to promote improved recipe and intervention package with 12 months of intervention period. 2. To improve young child feeding practices following counselling Methods: This will be a community based cluster randomized trial. Group I (intervention) will receive a package of intervention (child feeding counselling, WASH and micronutrient powder) along with food voucher to support feeding their children a homemade snack following a newly developed recipe (suzi firni for <1 year, suzi halua for >1 yr) and Group II (Control) will receive usual health meassages. Baseline and endline survey will be conducted. Growth Monitoring Promotion (GMP) will be done monthly to monitor the growth of the children and utilization of food voucher. Data on child feeding, morbidity and anthropometry (length and weight) will be collected monthly. Outcome measures/variables: 1. Difference in mean LAZ of the children between intervention and control group 2. Difference in mean weight for age Z-score (WAZ) of the children between intervention and control group 3. Difference in proportions of mothers in terms of correct knowledge and practice on CF