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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-12
SponsorSilviya Pavlova Nikolova, PhD

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nutrilect

Treatment groups

200 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Silviya Pavlova Nikolova, PhD

Lead sponsor

Medical University of Varna

Sponsor institution

European Union

Collaborator