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Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD

NCT06065904 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-10-04

No results posted yet for this study

Summary

The study is a prospective, single-center, randomized controlled trial that will be conducted at the Medical University of Varna. This setting offers access to a wealth of clinical expertise in managing CP and ASD and a rich tradition of conducting robust nutritional interventions.

Conditions

  • Nutrition Disorder, Child

Interventions

BEHAVIORAL

Nutrilect

This intervention involves a comprehensive approach that includes a thorough nutritional assessment and individualized nutrition plan for children with cerebral palsy (CP) and Autism Spectrum Disorder (ASD), addressing their unique dietary needs and challenges. It encompasses nutritional counseling, dietary modifications when necessary, and seamless integration with other therapies, including speech therapy and psychological consultation. The overarching goal is to optimize growth, muscle function, and overall well-being in these children by providing tailored nutritional support alongside a holistic care approach.

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Silviya Pavlova Nikolova, PhD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-12-23
Completion
2026-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065904 on ClinicalTrials.gov