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

Silviya Pavlova Nikolova, PhD

Status: Not yet enrolling

Conditions: Nutrition Disorder, Child

Treatments: Behavioral: Nutrilect

Study type: Interventional

Funder types: Other

Identifiers

NCT06065904

MUVarna

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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200 participants in 4 patient groups

CP with recommended diet

Experimental group

Description:

CP children that will follow a recommended menu

Treatment:

Behavioral: Nutrilect

CP with a standard of care nutritional menu

No Intervention group

Description:

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

ASD with recommended diet

Experimental group

Description:

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

Treatment:

Behavioral: Nutrilect

ASD with a standard of care nutritional menu

No Intervention group

Description:

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