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NCT ID: NCT06096194 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D3-enhanced Eggs in Preschool Children

VD3-egg
Start date: July 15, 2018
Phase: N/A
Study type: Interventional

This is double-blind, controlled fiel trial, to compare fortified egg with D3-or 25(OH)D3 and non-fortified eggs in healthy preschool-age children 12 to 60 months of age, affiliated to day-care centers at Secretaria de Desarrollo Social (SEDESOL). The study aims to answer are: 1. to evaluate the efficacy of fortified egg with vitamian D3 on serum concentrations of 25-hydroxyvitamin D3 2. and to evaluate parathyroid hormone (PTH) in children aged 12 to 60 months of age. - Children would be given for breakfast fortified egg/non-foritfied egg three times per week for 12 weeks. - Blood samples will be taken at baseline and at the end of study. - Anthropometric meassurements weight /height will be taken at baseline and at end of study.

NCT ID: NCT06094894 Completed - Gut Microbiota Clinical Trials

Effects of Sucralose in Gut Intestinal Microbiota and Postprandial GLP-1

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Recently, it has been proposed that the consumption of non-nutritive sweeteners, including sucralose, it's not harmless and is related with metabolic effects. Some studies have reported that sucralose produces alterations in glucose homeostasis. In vitro studies indicate that sucralose can interact with sweet taste receptors (T1R2 and T1R3) in the intestine, thus increasing the expression of glucose transporters including the sodium-glucose cotransporter type 1 (SGLT1) and the glucose transporter 2 (GLUT2), increasing glucose absorption. This interaction with intestinal sweet taste receptors also generates an increase in the secretion of the incretins glucagon-like peptide type 1 (GLP-1) and the glucose-dependent insulinotropic polypeptide (GIP), which might enhance the postprandial insulin release. However, these results are preliminary and it's desirable to confirm if sucralose consumption is associated with glucose metabolism modifications using an appropriate methodological design and with gold standard methods. The aim of this triple-blind, placebo-controlled, parallel, randomized clinical trial is to confirm the changes in insulin sensitivity associated with sucralose consumption in humans, to identify whether these changes are in the liver or skeletal muscle and to investigate the pathophysiological mechanisms generating these changes. Specifically, we will investigate if sucralose generates a dysbiosis in the gut microbiota that could be related to insulin resistance by increasing concentrations of lipopolysaccharide, a toxin found in Gram-negative bacteria that triggers a low-grade inflammation known as metabolic endotoxemia. In addition, the changes in postprandial concentrations of GLP-1, glucose, insulin, and C-peptide due to the combination of sucralose with a mixed meal will be investigated. The results of this study will determine if sucralose consumption, frequently used as a non-nutritive sweetener, is associated to significant changes in glucose homeostasis in humans.

NCT ID: NCT06090747 Recruiting - Breast Neoplasm Clinical Trials

Improving Lifestyle Behavior by "Joven, Fuerte y Saludable" Multidisciplinary Program.

Start date: March 9, 2023
Phase: N/A
Study type: Interventional

Breast cancer is the leading cause of mortality in women worldwide. Latin-American women are diagnosed at younger ages, in advanced stages, and with aggressive molecular subtypes. Lifestyle seems related to these aggressive conditions and worse outcomes. The present study seeks to evaluate the effect of a hybrid multidisciplinary intervention for implementing a healthy lifestyle to modify the personal and internal exposome of young women with breast cancer. This randomized controlled experimental study with two groups: Group 1: Hybrid multidisciplinary lifestyle education intervention. Group 2: Individualized hybrid multidisciplinary lifestyle interventions. The multidisciplinary lifestyle intervention program includes oncology, nutrition, physiotherapy, and psychology interventions.

NCT ID: NCT06087835 Recruiting - Clinical trials for Chronic Kidney Disease With High Proteinuria

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Start date: November 7, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria.

NCT ID: NCT06083675 Withdrawn - Clinical trials for Diabetes Mellitus, Type 2

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Start date: January 26, 2024
Phase: Phase 3
Study type: Interventional

This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

NCT ID: NCT06080841 Recruiting - Clinical trials for Locally Advanced Cervical Cancer

Curcumin Supplementation in Cervical Cancer

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

Brief Summary. The goal of this pilot study is to learn about the effect of curcumin supplementation in locally advanced cervical cancer patients. The main questions it aims to answer are: - Does curcumin supplementation increase the levels of p53 and apoptosis in tumor cells from cervical cancer patients? - At which dose of curcumin supplementation is the broader effect observed for p53 expression and apoptosis in tumor cells from cervical cancer patients? - Are all doses safe for supplementation? Participants will be asked to take curcumin tablets throughout their cancer treatment. Researchers will compare 6 different groups, each group will receive a different dose of curcumin with or without piperin, to see the dose with the broader effect and safety of curcumin supplementation: 1. 1 g of curcumin 2. 1 g of curcumin + piperine 3. 3 g of curcumin 4. 3 g of curcumin + piperine 5. 6 g of curcumin 6. 6 g of curcumin + piperine

NCT ID: NCT06080139 Active, not recruiting - Refugee Health Clinical Trials

Supporting Refugee Parenting Community and Family Mental Health in Tijuana

Start date: February 6, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to better understand and support parenting practices and family mental health among migrant parents in Tijuana, Mexico. the main questions it aims to answer are: 1. What parenting skills are most needed for learning? 2. How can we teach them in a participatory way respecting cultural values and norms? 3. How does this parenting program affect parental and child interactions and mental health? Participants will 1. have the opportunity to give their opinions on the priority parenting skills needed and on which curriculum to use for learning these skills; 2. participate in small group learning sessions twice a week for 4 weeks; 3. be asked to complete a few surveys before and after the learning sessions, and 2 months after they complete the learning sessions. Researchers will compare parents randomly assigned to parenting sessions group with waitlist control group (starting learning sessions 1 month later) to see if the group learning benefits parent-child interactions, parental stress, and parental confidence in parenting.

NCT ID: NCT06079671 Recruiting - Clinical trials for Locally Advanced Cervical Cancer

Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)

eVOLVECervical
Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIC to IVA cervical cancer with lymph node involvement) who have not progressed following platinum-based CCRT.

NCT ID: NCT06079359 Recruiting - Hypophosphatasia Clinical Trials

Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP

MULBERRY
Start date: May 14, 2024
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.

NCT ID: NCT06077864 Recruiting - Obesity Clinical Trials

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

Start date: November 17, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.