Status:
NOT_YET_RECRUITING
Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD
Lead Sponsor:
Silviya Pavlova Nikolova, PhD
Collaborating Sponsors:
European Union
Conditions:
Nutrition Disorder, Child
Eligibility:
All Genders
2-12 years
Phase:
NA
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 managi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06065904
Start Date
October 1 2023
End Date
July 30 2026
Last Update
October 4 2023
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