Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062916) titled 'Development and Evaluation of a Web-based Nutrition Management Application for Patients Requiring Special Dietary Therapy and Their Families' on Sept. 14.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Fukuoka University

Condition: Condition - Inborn errors of metabolism, Intractable epilepsy (ketogenic diet-eligible cases) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the impact of a web-based application that automatically calculates disease-specific nutrient intake on dietary therapy adherence, disease management indicators, and patient satisfaction before and after the intervention in patients with inborn errors of metabolism and intractable epilepsy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Nutrition management support using the developed web-based application (DiANA app). Patients and their families will be provided with access to the web application via QR code or URL and encouraged to use it freely for daily dietary management. The application automatically calculates methionine, protein, and calorie content of foods, as well as the ketogenic ratio derived from fat, carbohydrate, and protein content. The application is accessible from smartphones, tablets, and personal computers. The intervention period is 6 months, and a registered dietitian will confirm the usage status at each outpatient visit.

Eligibility: Age-lower limit - 6 months-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with inborn errors of metabolism requiring daily nutritional management 2. Patients requiring ketogenic diet therapy for seizure management 3. Patients or their families who regularly use a smartphone or tablet device 4. Patients who have started weaning (complementary feeding) 5. Patients or their legally authorized representatives who have provided written informed consent Key exclusion criteria - 1. Patients or their families who do not own a smartphone or tablet device 2. Family members of the principal investigator or co-investigators 3. Others whom the principal investigator deems inappropriate for participation in the study Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 07 Day Date of IRB - 2026 Year 09 Month 07 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072032

Disclaimer: Curated by HT Syndication.