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Malnutrition clinical trials

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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

NCT ID: NCT03634488 Completed - Sickle Cell Anemia Clinical Trials

Management of Severe Acute Malnutrition in SCD, in Northern Nigeria

Start date: August 18, 2021
Phase: Phase 2
Study type: Interventional

Except for children with HIV, all recommendations for treatment of childhood malnutrition are for children < 5 years of age. The overall goal of this randomized controlled nutrition feasibility trial is to identify whether families of children with sickle cell disease (SCD) 5 years and older agree to participate over a 12-week period. The investigators will also establish a safety protocol for monitoring potential complications associated with treating severe malnutrition in children 5 years and older with and without SCD, in a low-resource setting.

NCT ID: NCT03631537 Not yet recruiting - Malnutrition Clinical Trials

Nutrition-support-team Based Intervention in Patients With Advanced Gastrointestinal Cancer

NSTBIPAGC
Start date: August 20, 2018
Phase: N/A
Study type: Interventional

The research studies patients with advanced gastrointestinal cancer who receive chemotherapy in the medical oncology department of the First Affiliated Hospital of Xian Jiaotong University. All patients receive the nutritional risk assessment by the nutritional support team first, and patients with nutritional risk or malnutrition are randomly assigned to the study group and the control group. The study group receive nutritional intervention from the nutritional support team during the period of chemotherapy, while the control group receive routine nutritional support from their clinicians. In the control group, nurses execute the doctors' advice on nutrition, and the nutrition support team does not actively communicate with doctors about the nutritional risk of patients or interfere with it. The baseline characteristics, chemotherapy efficacy, adverse events and prognosis are collected in both groups. At last, data are analyzed to clarify the nutritional status and related factors of patients with advanced gastrointestinal cancer in our hospital, and most important to explore the effect of nutrition-support-team intervention on nutritional status, chemotherapy tolerance and prognosis of patients with advanced gastrointestinal cancer.

NCT ID: NCT03628196 Completed - Malnutrition Clinical Trials

A Nutrition-Focused QIP in Outpatient Clinics

Start date: September 26, 2018
Phase:
Study type: Observational

A nutrition-focused QIP will be implemented with a primary assessment of QIP feasibility, patient health and economic outcomes as well as patient and provider experience data. A 2-phased QIP study group will be prospectively enrolled from outpatient clinics affiliated with the USC health system and compared with historical and concurrent control groups.

NCT ID: NCT03627910 Recruiting - Malnutrition Clinical Trials

Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy and Their Relationship With Gut Microbiota

Start date: June 11, 2017
Phase: N/A
Study type: Interventional

Participants will be randomly assigned to the experimental group where they will be given enteral nutrition formula rich in zinc and arginine plus a symbiotic (Probinul- Ca.Di.GROUP S.r.l.) once a day for 90 days or the control group where they will receive only the enteral nutrition formula rich in zinc and arginine.

NCT ID: NCT03606603 Completed - Malnutrition Clinical Trials

Nutrition Insights Day Asia

Start date: March 15, 2019
Phase:
Study type: Observational

This is an observational, cross-sectional study to be conducted on the Nutrition Insights Day (NID), with retrospective review of patient medical charts. No prospective follow-up period is considered. This study aims to obtain a contemporary overview of the nutritional status, the use of EN and/or PN and the provision of calories and proteins in patients after major elective gastrointestinal surgery with existing malnutrition or at risk of hospital malnutrition in selected Asian countries.

NCT ID: NCT03602274 Recruiting - Malnutrition Clinical Trials

APAP Hepatotoxicity After Therapeutic Doses

Start date: February 10, 2015
Phase:
Study type: Observational

Paracetamol (acetaminophen, APAP) is the most commonly used antipyretic and painkiller worldwide, but also the leading cause of acute liver failure (ALF) in developed countries after supra-therapeutic doses (half overdoses being unintentional). At therapeutic doses (4g/day), up to one third of healthy volunteers develop liver test elevation and cases of ALF have been described in the presence of suggested risk factors such as malnutrition, fasting and low body weight as a result of glutathione depletion. However, no well conducted study has aimed to prospectively assess the impact of malnutrition/fasting on the toxicity to therapeutic doses of APAP. Considering the widespread use of APAP and the prevalence of malnutrition in hospitalized patients (up to 30%), it is of crucial importance to assess whether these patients are at higher risk of hepatotoxicity. It is indeed likely that cases of liver damage secondary to normal recommended dose are under-estimated in these situations as the dose is not perceived as excessive and not described as such in international guidelines for pain management. The primary objective of our project will therefore be to assess if malnutrition and fasting are risk factors for liver toxicity after therapeutic doses (4g/day) of APAP in surgery patients. The second objective will be to evaluate the pharmacokinetics of APAP and metabolites according to nutrition status in order to establish, if necessary, dose reduction guidelines. Developing and validating an early and easily accessible marker of hepatotoxicity would especially be useful in these putative higher risk and fragile populations in order to improve early detection diagnosis and allow earlier management.

NCT ID: NCT03600610 Not yet recruiting - Anorexia Nervosa Clinical Trials

Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa

CARERA
Start date: September 2018
Phase: N/A
Study type: Interventional

Anorexia nervosa is an eating disorder occurring in adolescent females, characterized by voluntary dietary restriction, intense fear of gaining weight, and disturbed body image perception. Anorexia nervosa is characterized by the potential severity of its prognosis. While complete remission occurs in about 50% of cases, up to 20% of patients will develop a chronic relapsing form that leads to social disintegration. Moreover, anorexia nervosa has the highest mortality rate among psychiatric diseases with a risk of death of up to 10%. 30% of deaths in anorexia nervosa are attributed to cardiac complications remaining insufficiently described, and their screening at a preclinical stage is still poorly codified. Echocardiography findings show reduced left ventricular mass, pericardial effusion or mitral valve prolapse ; in addition, systolic function appears to be preserved whereas a global diastolic dysfunction, estimated with trans-mitral flow and global longitudinal strain. While the interest of cardiac echography has been well established, only one study used MRI as a means of cardiac evaluation in anorexia nervosa: interestingly, local myocardial fibrosis is pointed and could potentially contribute to cardiac rhythm disorders. No study has yet used T1-Mapping MRI to evaluate if diffuse myocardial fibrosis is prevalent in this population group. The investigators conduct a transversal, observational, monocentric study whereby malnourished patients with anorexia nervosa and age- and sex- matched, normal weight, healthy volunteers will undergo a gadolinium-enhanced cardiac MRI. The primary objective of this study is to evaluate and compare the frequency of cardiac fibrosis in those populations. Other cardiac MRI parameters will be described and compared as secondary objectives. Moreover, non-cardiac parameters evaluated by MRI such as adipose tissue distribution in anorexia nervosa patients compared with controls. In addition, patients with anorexia nervosa, a clinical, morphological and biological evaluation, including anthropometric parameters, biphotonic absorptiometry, resting electrocardiogram, cardiac echography and classical biological markers of malnutrition, will be done.

NCT ID: NCT03598842 Active, not recruiting - Tuberculosis Clinical Trials

Tuberculosis - Learning the Impact of Nutrition

TB-LION
Start date: July 12, 2019
Phase: N/A
Study type: Interventional

The proposed work is based on the finding that one-third of the world is infected with the bacteria Mycobacterium tuberculosis (Mtb) and only 10% of these individuals develop TB. The study aims to identify factors that drive progression to disease and study signals (markers of the immune response) that detect who will progress to active TB and why this happens. Armed with these markers, the study will address how malnutrition and worms alter this signal profile to cause active TB. The work will be conducted in India, where there are 2.8 million TB cases each year - more than any other country - and where the government has committed to eliminating TB by 2035. Data suggest that malnutrition and parasites increase risk of TB disease so the investigators will feed malnourished household contacts and have those with parasites receive medication to treat these. Using this infrastructure, the investigators will evaluate the immunologic impact of feeding on TB pathogenesis. An additional aim is to understand the role of parasitic worms with the goal of determining the utility of low-cost ($.02 per dose) worm treatment as part of TB control efforts. Risk of developing TB will be evaluated for 120 household contacts of TB patients in the setting of their malnutrition and parasites. There are four study arms comprised of thirty participants each -- malnourished with parasite infection, malnourished with no parasite infection, well-nourished with parasite infection, and well-nourished with no parasite infection. Correlates of risk of disease will be assessed using blood messenger RNA/micro RNA (mRNA/miRNA) sequencing and T cell immune markers. The TB LION study will confirm that malnutrition and worms increase the risk of active TB and will provide the basis for effective interventions that could change the face of the TB pandemic and have a profound impact on the health of people worldwide. Participants in this study will be household contacts of tuberculosis index cases. The index cases in this study do not participate in the study once a household contact is established. All interventions and follow up are only being conducted within the household contact cohort. All intervention supplies, treatments, and biologics will be purchased internationally.

NCT ID: NCT03598413 Completed - Colorectal Cancer Clinical Trials

PeRioperative Omega Three and the Effect on ImmuNity

PROTEIN
Start date: July 16, 2018
Phase: N/A
Study type: Interventional

Bowel cancer is the second most common cause of cancer-related death in the UK, with 50,000 new cases and over 15,000 deaths annually. Surgery is the mainstay of treatment and the most common complications are an infection of the wound or lungs. These can lengthen hospital stay, reduce the quality of life, and even increase the risk of death. Bowel cancer patients are often malnourished. Optimising nutrition with supplements such as fish-oils can improve the immune response of patients, helping prevent such complications, shorten hospital stay, improve quality of life and overall survival.