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Malnutrition clinical trials

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NCT ID: NCT06130228 Not yet recruiting - Obesity Clinical Trials

Nutritional Therapy in Late-onset Pompe Disease

PDT-MIS
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

RATIONALE: Pompe disease (PD) is a recessive genetic disorder wherein the body cannot break down glycogen due to a mutation in the acid alpha glucosidase (GAA) gene, which encodes for acid alpha-glucosidase. The adult/late onset form (LOPD) leads to glycogen accumulation and autophagic buildup, causing progressive muscle weakness that leads to wheelchair dependence, reduced quality of life and premature death due to cardiorespiratory insufficiency. While nutritional strategies, such as the low carbohydrate/high protein and ketogenic diets, have been used clinically, they are difficult to maintain and have limited benefits. Multi-ingredient supplementation (MIS) allows for targeting of several underlying pathogenic pathways and may be more convenient than traditional dietary strategies, thereby improving both adherence and LOPD pathology.

NCT ID: NCT06114199 Not yet recruiting - Clinical trials for Nutritional Deficiency in Pregnancy

Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Harris Health System is currently participating, along with two other partners, GoldiFresh Inc., and Brighter Bites, in a cross-sector collaborative home delivery-based Produce Prescription Program (PPRx) pilot initiative that provides consistent access to healthy food plus nutrition education to Medicaid-eligible pregnant women in Harris County, TX, deemed to be at high risk of adverse pregnancy or birth outcomes. The objectives of this study are two-fold: (a) to examine utilization of food basket contents and improvements in diet quality in this home delivery based PPRx program, and (b) to evaluate if and the extent to which utilization of food basket contents outcomes improves with support from an interactive AI-based conversational agent to convert food into healthy meals.

NCT ID: NCT06102473 Not yet recruiting - Clinical trials for Overweight and Obesity

Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effect of a digital educational intervention of front-of-package warning labeling on the selection and purchase of food in elementary school children and their caregivers. The main question it aims to answer is: - What is the effect of a digital educational intervention on front-of-package warning labeling on food selection in children from primary schools in Mexico City, compared to a control group? Participants will be randomized into two groups. - The control group, the dyads (caregiver-schoolchildren), will receive general nutritional education. - The intervention group, will also receive guidance on reading labels and raise awareness about the impact of consuming processed or ultra-processed foods on health. The intervention will be carried out through a web page with audiovisual material and all participants also will be asked to complete: - Multiple-choice evaluation (5 questions) to ensure theoretical understanding of the topics - Lunch register - 24-hour dietary recall - Survey of food habits and consumption - Validated food preference questionnaire - Anthropometric measurements (Weight, height, waist circumference, body mass index) - Socioeconomic survey - Participate in a simulated online selection and shopping of food and beverages. To see if the digital educational intervention in the front of package warning labeling in children and caregivers will improve the selection and purchase of foods.

NCT ID: NCT06062914 Not yet recruiting - Malnutrition Clinical Trials

Health Economic Research on Oral Nutritional Supplements for Hospitalized Patients With Nutritional Risk

Start date: October 7, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate the treatment effect and health economic impact of oral nutritional supplements(ONS) in hospitalized patients with nutritional risk. The main questions it aims to answer are: - To evaluate the effect of ONS on clinical outcomes in hospitalized patients with high nutritional risk - To evaluate the health economic impact of ONS in hospitalized patients with high nutritional risk Data was collected from patients admitted to peking union medical college hospital between January 1, 2018 and December 31, 2020. The inclusion criteria were as follows: (1) age≥18 years old; (2)length of hospital stay≥3days; (3) Only ONS was used as enteral nutrition or no enteral nutrition was received. Exclusion criteria were: (1) age<18; (2) length of hospital stay<3 days; (3) the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions; (5) the patients who transferred from other hospitals; (6) pregnancy or lactation We collected the following data through the hospital big data query and analysis system: 1. Basic information: gender, age, height, weight, medical insurance, etc. 2. Clinical information: admission paths, admission time, admission departments, discharge time, discharge unit, length of stay, mode of payment; 3. Disease Information: admission diagnosis, disease coding at admission, the first discharge diagnosis, the coding of first discharge diagnosis, the second discharge diagnosis, the third discharge diagnosis, outcome (recovery, improvement, not cured, death, transfer to another hospital) 4. Operation information: surgical name, surgery code, 5. oral nutritional supplement: drug names, unit price 6. laboratory examination: hemoglobin, albumin, prealbumin 7. hospitalization costs: total cost, self-pay cost, other cost, the type of medical insurance; Researchers will compare ONS group to see the clinical outcomes and health economic impact.

NCT ID: NCT06061484 Not yet recruiting - Clinical trials for Severe Acute Malnutrition

Modified Dosage for Severe Acute Malnutrition

MODAM-SAM
Start date: September 25, 2023
Phase: N/A
Study type: Interventional

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current weight-based dosing of RUTF for children with SAM.

NCT ID: NCT06056089 Not yet recruiting - Clinical trials for Moderate Acute Malnutrition

Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)

MODAM-MAM
Start date: September 25, 2023
Phase: N/A
Study type: Interventional

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current fixed-dose regimen of RUTS for children with MAM.

NCT ID: NCT06049680 Not yet recruiting - Malnutrition Clinical Trials

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Start date: May 2024
Phase: Phase 4
Study type: Interventional

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.

NCT ID: NCT06047054 Not yet recruiting - Malnutrition Clinical Trials

Incidence Rate and Risk Factors of Malnutrition in ICU

Start date: September 2023
Phase:
Study type: Observational

To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition

NCT ID: NCT06045104 Not yet recruiting - Clinical trials for Moderate Acute Malnutrition

Alternative Feeding Regimen on Recovery of Children Aged 6-59 Months With Moderate Acute Malnutrition in Bangladesh.

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

In spite of the large burden of acute malnutrition in the country, the Community-based Management of Acute Malnutrition (CMAM) protocol approved in Bangladesh highly deviates from the WHO normative guidance, in that it does not support the use of any currently existing nutritional products for Moderate Acute Malnutrition (MAM) cases: it relies solely on nutrition counselling. On another hand, some non-governmental organizations (NGOs) are implementing programs making a standard use of specialized nutritional products, such as nutritional supplements like Wheat Soy Blend (WSB)++ to manage MAM cases, in children of Forcibly Displaced Myanmar Nationals (FDMNs) in the refugee camps situated at the south-eastern region of the country and in some crisis-affected districts as well. The "no-food" CMAM policy for MAM is decreasing the cost of treatment, yet this may undermine effectiveness and impact. In this context, policy makers need evidence regarding context specific, effective and scalable interventions for CMAM. This cluster randomized control trial (cRCT) will be conducted in the host communities in Teknaf and Ukhiya sub-districts of Cox's Bazar district of Bangladesh among children aged 6-59 months suffering from MAM who will be assigned to receive either of the 2 different treatment packages for a period of 4 months (120 days). Then followed up for 6 months (180 days) post treatment completion. Each arm will consist of 280 children with MAM. Both the arms will receive nutrition counselling along with the study intervention, as follows: In the first arm, the treatment packages for children with MAM will include a standard use of specialized nutritional products developed to address the nutritional needs of these children in acute crisis/emergency settings and widely used internationally: children with MAM will receive WSB++ with nutrition counselling for a period of 4 months (120 days),. In the second arm, children with MAM will receive 15 MNP with improved nutrition counselling for a period of 4 months (120 days). A cluster sampling technique will be used to enroll participants. Each Community Clinic and Union Health & Family Welfare Centers will serve as unit of cluster for the randomization. Primary outcome variables are: 1) Daily weight gain (g/kg/d) between enrolment and end of the treatment period. 2) Recovery rate (%) at the end of the treatment period.

NCT ID: NCT06038071 Not yet recruiting - Clinical trials for Severe Acute Malnutrition

Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)

MODAM-fMUAC
Start date: September 25, 2023
Phase: N/A
Study type: Interventional

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. For the Family MUAC follow-up study, children who recover from these two parallel clinical trials will be enrolled in trial to test the effectiveness of MUAC screening at home by the child's caregivers as a self-referral strategy, compared to a scheduled health facility-led strategy and the standard of care of community-based follow-up visits.