NCT03933709

Effect of a Nutritional Support System for Improving Gross Motor Function in Cerebral Palsy

CONTROLLED, RANDOMIZED, BLIND CLINICAL TRIAL OF EFFECT OF A NUTRITIONAL SUPPORT SYSTEM (DIET, SUPPLEMENTS AND PROBIOTIC) FOR IMPROVING GROSS MOTOR FUNCTION IN CEREBRAL PALSY

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Anahuac University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Background: Most patients with cerebral palsy (CP) are dependent on parents due to the spasticity and limitations in their gross motor function. Additionally, many of them do not respond to physical therapy due to deterioration in their nutritional status, which is secondary to gastrointestinal disorders, parasitosis, dysbiosis and the catabolic state of the disease itself. Evidence suggests that greater independence and better clinical response can be achieved by correcting the nutritional status. However, basic treatments only contemplate the calculation of energy requirements and do not consider important nutrients in particular, supplementation with glutamine, arginine, zinc, selenium, colecalciferol, nicotinic acid, spirulina, omega 3, ascorbic acid, vegetal protein or even probiotics. Objective: To determine the effect of using a nutritional support system (NSS) diet, supplements and probiotic on the gross motor function in children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III). Material and methods: In an exploratory study with controlled clinical trial design, 30 patients were randomly assigned to receive: 1) dietary surveillance and conventional therapy (FG), 2) deworming and WHO diet (CG), or 3) deworming and the NSS (IG). The patients were recruited from the Children´s Telethon Rehabilitation Center (CRIT) in Tlalnepantla Estado de México. Males and females aged 4-12 years were included with CP and spastic diparesic GMFCS III, who had a full-time caregiver and whose parents agreed to participate. They were studied for thirteen weeks. Gross motor function was evaluated at baseline and at 7 and 13 weeks after therapy using the GMFM scale.

Conditions

• Nutrition Disorder, Child
• Gross Motor Development Delay
• Neuro: Cerebral Palsy
• Diet Modification
• Probiotics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional Support System (NSS)	Envelope 1 4.9g of Spirulina, 100mg ascorbic acid, 5mg folic acid and 10mg of glutamine. Was to be added to shake 1 during the first 10 days. Envelope 2 1g PUFAs n-3 and was to be added to shake 2 which was given throughout the intervention. Envelope 3 4.9g of Spirulina Maximum, 100mg ascorbic acid, 5mg folic acid, 5.2g vegetable protein, 125mg nicotinic acid, 50mg zinc, 100 mcg selenium and 800 UI cholecalciferol. Was to be added to shake 1 from day 11 until the end of week 6, after which it was suspended for 10 days and substituted for envelope 5 and then to be retaken until the end of the intervention. Envelope 4. 1g arginine and was to be added to shake 3 from day 8 until the end of the intervention. Envelope 5 contained the same ingredients as envelope 3 with an additional 10mg glutamine and was to be added to shake 1 from the start of week 7 for 10 days, after which envelope 3 was restarted. Probiotic at a dosage of 200 mg every 12 hours for 3 days at the beginning and week 6
OTHER	deworming	nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days.
OTHER	recommended diet	WHO Diet

Timeline

• Start date: 2015-01-12
• Primary completion: 2015-12-18
• Completion: 2017-04-07
• First posted: 2019-05-01
• Last updated: 2019-05-01