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

NCT06065904 | Not Yet Recruiting DMC

• 1 other identifier: MUVarna
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• bedridden days monthsmean duration of bedridden days over six months

  mean duration of bedridden days

  six months

Secondary Outcomes (7)

• Weight-for-Age Z-Score

  six months

• Height-for-Age Z-Score

  six months

• BMI-for-Age Z-Score

  six months

• Number of social interactions per week with non-family members

  six months

• Total Number of New Spoken Words per Month

  six months

Study Arms (4)

CP with recommended diet

EXPERIMENTAL

CP children that will follow a recommended menu

Behavioral: Nutrilect

CP with a standard of care nutritional menu

NO INTERVENTION

Children with CP that will not be advised on a specific menu

ASD with recommended diet

EXPERIMENTAL

Children with ASD that will not be advised on a specific menu

Behavioral: Nutrilect

ASD with a standard of care nutritional menu

NO INTERVENTION

Children with ASD that will not be advised on a specific menu

Interventions

Nutrilect BEHAVIORAL

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.

ASD with recommended diet; CP with recommended diet

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A formal diagnosis made by a qualified neurologist. The diagnosis can span across the different types of CP and ASD.
• Expressed willingness to participate in the study.
• Availability for the entire duration of the study.

You may not qualify if:

• Children with acute medical conditions or comorbidities that may significantly disrupt study assessments.
• Any severe infections within the last 10 days prior to the study.
• Presence of genetic syndromes that could influence nutritional status, e.g., Silver Russel syndrome or Down syndrome.
• Parents with cognitive impairments, which might pose challenges in their participation during assessments/intervention.
• Children who have been part of any major dietary or nutritional interventions in the last three months.

Sponsors & Collaborators

• Silviya Pavlova Nikolova, PhD: lead
• European Union: collaborator

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The research is financed by the European Union-NextGenerationEU, through the National Recovery and Resilience Plan of the Republic of Bulgaria, project № BG-RRP-2.004-0009-C02.

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: October 4, 2023
• Study Start: October 1, 2023
• Primary Completion: December 23, 2024
• Study Completion (Estimated): July 30, 2026
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share