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Malnutrition clinical trials

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NCT ID: NCT04700293 Completed - Malnutrition Clinical Trials

Tolerance and Acceptability Evaluation of AYMES AMSTERDAM

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

NCT ID: NCT04698070 Completed - Clinical trials for Acute Malnutrition in Infancy (Disorder)

Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Niger (OptIMA Niger)

Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Acute malnutrition (AM) is a continuum condition, arbitrarily divided into severe and moderate categories (SAM, MAM) which are managed separately, with programs overseen by different agencies with different products and supply chains. Such separation complicates delivery of care, contributes to poor program performance, and creates confusion among caregivers. Reduction in the mortality burden from AM will stem from improved simplicity, efficiency and cost-effectiveness of current protocols. Eligibility for SAM treatment in the current Niger protocol is complex. It is determined by 3 independent criteria: nutritional oedema, Mid-Upper Arm Circumference (MUAC) < 115 mm or weight-height Z score (WHZ) <-3. Also, the Ready to Use Therapeutic Food (RUTF) ration in Niger protocol (130-200 kcal/kg/d) is paradoxical. The amount of RUTF prescribed in the first weeks of treatment is often less than what given to child reaching recovery (MUAC > 125 and WHZ >-2), because weekly ration is determined by the child's weight. Rate of weight gain is highest in the first two weeks of treatment, then plateaus - suggesting no benefit of increased RUTF ration at the end of treatment. Progressive reduction is a more rational use of RUTF and this supplement is equally effective for SAM and MAM. This community-based non-inferiority trial will compare two strategies for the treatment of AM to the Niger protocol for SAM and MAM. The Optimizing treatment for acute MAlnutrition (OptiMA) strategy uses MUAC < 125 mm or nutritional oedema as admission criteria and optimizes RUTF by adapting doses to the degree of malnutrition. RUTF dose for MUAC < 115 mm or oedema is 170 kcal/kg/d and progressively reduces to 75 kcal/kg/d as MUAC increases. The Combined Protocol for Acute Malnutrition Study (ComPAS) uses the same eligibility criteria like OptiMA, but simplifies more the RUTF ration by providing 1000 kcal/d for children with oedema or MUAC < 115 mm and 500 kg/d for children with MUAC 115-124 mm. Children are considered recovered if they have 2 consecutive weekly MUAC measures ≥ 125 mm. Children will be individually randomized to treatment in one of the 3 study arms and will attend clinic visits weekly until nutritional recovery. After discharged, they will be monitored monthly via a nurse-conducted home visits until 6 months post-inclusion. The trial arms will be compared using a composite outcome indicator that includes vital status, anthropometric measures and relapse following the index AM episode. The hypothesis is that simplified strategies could substantially increase the number of children in care compared to current SAM programs without requiring additional RUTF or staffing while maintaining recovery rates in line with current programs.

NCT ID: NCT04696367 Completed - Surgery Clinical Trials

Impact of Nutritional Deficit in Emergency Surgery

INDIcatES
Start date: January 1, 2020
Phase:
Study type: Observational

Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

NCT ID: NCT04694898 Completed - Anemia Clinical Trials

Sustainable Undernutrition Reduction in Ethiopia

SURE
Start date: December 28, 2020
Phase: N/A
Study type: Interventional

The causes of malnutrition are complex and addressing the problem requires integrated action among various sectors. Globally, much attention has been given to nutrition-specific interventions to address the immediate causes of undernutrition. But undernutrition prevalence is decreasing at a very slow rate. Nutrition-specific interventions address the immediate determinants of child undernutrition, such as inadequate food and nutrient intake, but do not consider the underlying causes such as food insecurity, poverty, and limited access to clean water, hygienic environments, and health services. Ethiopia still has a high prevalence of undernutrition. The current situation of food insecurity and malnutrition in Ethiopia has pressurized the government in pursuing a number of nutritional-sensitive interventions to increase diversified food production and consumption like the Sustainable Undernutrition Reduction Program (SURE). This study aims to investigate whether joint nutrition specific and sensitive interventions can lead to improved household food security, dietary diversification and improved nutritional status in Ethiopian mothers and their young children. The study will be a community based longitudinal design and will use multistage cluster sampling at the Kebele and household levels in Amhara, Oromia, and Southern Nations, Nationalities, and Peoples' Region (SNNPR) regions. Households will be randomly selected from the intervention and the non-intervention arms at Kebele level, with 15 households per Kebele. The same children whose baseline are available who were 0-23 months of age at the time of the baseline assessment in 2016 will be recruited as well as their mothers. This represents approximately third of the total sample size at baseline.

NCT ID: NCT04689919 Completed - Bioequivalence Clinical Trials

Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions

Bioequivalence
Start date: February 19, 2022
Phase: Phase 1
Study type: Interventional

A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg tablet under fed conditions in healthy Pakistani male subjects. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days. Blood samples will be taken up to 48hours post-dose.

NCT ID: NCT04688515 Completed - Malnutrition, Child Clinical Trials

Effectiveness of a Positive Deviance Program in Reducing Childhood Undernutrition

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

Globally, childhood malnutrition remains a public health concern. Malnutrition can be diverse from undernutrition to overnutrition. A young child, primarily refers to those under the age of 5, is suffering from undernutrition when the child is lacking of adequate nutrition that necessary for proper growth and health due to direct or indirect causes such as not having enough food. In fully urbanized area such as Kuala Lumpur, urban poor children tend to face greater deprivations such as lower education and poor health which significantly influence their daily diet and nutritional status. Hence, urban poor children who are living and growing up in such underprivileged environment should not be neglected. Since young children are generally depending on maternal feeding for daily diet, intervention that focus on encouraging positive change in maternal feeding practices might be efficient in reducing childhood undernutrition. The positive deviance (PD) approach may consider as a better alternative to empower mothers by promoting new behaviour to feed their children. Hence, this study aims to evaluate the effectiveness of a nutrition program using PD approach in reducing undernutrition among urban poor children aged 3 to 5 years old in Kuala Lumpur.

NCT ID: NCT04667767 Completed - Clinical trials for Severe Acute Malnutrition

The TISA Trial - Senegal

TISA
Start date: December 22, 2020
Phase: N/A
Study type: Interventional

This study evaluates the addition of a simple, scalable "WASH kit", including household water treatment products, a safe water storage container, and hygiene promotion, to the standard national protocol for outpatient treatment of uncomplicated severe acute malnutrition among children aged 6-59 months of age in northern Senegal.

NCT ID: NCT04655664 Completed - Clinical trials for Nutritional Deficiency

The Use of the 25 (OH) D Saliva Test as a Substitute for the 25 (OH) D Serum Test in Healthy People

Start date: April 11, 2020
Phase: N/A
Study type: Interventional

Routine examination of vitamin D levels is carried out by checking serum 25 (OH)D levels, which indicate circulating vitamin D levels. While serum 1.25 (OH) D levels are less frequently utilized, they represent the active form of vitamin D and could be a substitute for checking vitamin D levels. This study aims to find the correlation between vitamin D levels, namely 25 (OH) D and 1.25 (OH) D saliva, which correlate with serum 25 (OH) D and 1.25 (OH) D levels in the examination of salivary vitamin D, and which could be a substitute for checking serum vitamin D levels.

NCT ID: NCT04655456 Completed - Sarcopenia Clinical Trials

Feasibility of Estimating the Prevalence of Malnutrition, Frailty and Sarcopenia in Older People in UK Biobank, Cross-sectional Study: A Study Protocol

Start date: April 1, 2007
Phase:
Study type: Observational [Patient Registry]

Background: measuring the prevalence of malnutrition, frailty and sarcopenia in same group of older adults is effective in understanding the relation between these conditions. This could support diagnosing, treatment and prevention in future practice. The research is aiming to measure the estimate prevalence of malnutrition, frailty, sarcopenia and their overlap in older adults, using the UK Biobank. In addition, it will aim to compare the two models of frailty the phenotype and deficit accumulation using the UK Biobank database, as data comparing these models is limited. Methods/design: This is a cross-sectional study design that will use the UK Biobank database, which includes 381,000 participants males and females, aged 50 years and above, who completed the UK Biobank baseline assessments were included that is a subset from the main sample size from the UK Biobank. For baseline, details of participant's characteristics will be included. All three conditions will be identified as malnutrition by using GLIM criteria, while frailty by using two models; the first model will be the 36 deficits model and phenotype model. Finally, sarcopenia condition will be judge according to EWGSOP standard. All these models will be determining the feasibility to apply it using the available database in the UK Biobank. Discussion: This proposed study will help in understanding the relation between malnutrition, frailty and sarcopenia. As in worldwide, there is little published research on the overlap between malnutrition, frailty and sarcopenia. Despite definitions and diagnostic criteria were developed for these conditions. There is conflict extend to the definitions and identification criteria's. This study will use UK Biobank database to measuring the estimate prevalence in older people and determine the overlap between three conditions.

NCT ID: NCT04643626 Completed - Weight Change, Body Clinical Trials

The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Multi-center prospective pilot trial study