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Effect of the Nutritional Support System on Neuromotor Alterations in Patients With Cerebral Palsy

NCT05648422 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-02-01

No results posted yet for this study

Summary

Study to determine the impact of a nutritional support system (NSS) on neuromotor alterations in patients with cerebral palsy.

Conditions

  • Cerebral Palsy
  • Spastic
  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

Probiotics

Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9

DIETARY_SUPPLEMENT

NSS Nutritional Support System

Nutritional Support System consists in NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, glycine, tryptophan, and inuline) every 12 hours for 12 weeks.

DRUG

Deworming

nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days

OTHER

Specific diet

This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of smoothies at breakfast and dinner, high consumption of fish, five meals during the day, 70% of meals eaten during the day will consist on vegetables, fruits, roots, cereals, and legumes. Red meat, gluten, lactose, junk food, sugar, salt, fast food free.

OTHER

Conventional diet (WHO)

This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of general nutricional recommendations.

Sponsors & Collaborators

  • Anahuac University

    lead OTHER

Principal Investigators

  • Fernando Leal, PhD · Anahuac University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Mexico

Study Locations

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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 NCT05648422 on ClinicalTrials.gov