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

NCT ID: NCT03933709

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-12
• Study Completion Date: 2017-04-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Follow-up Group (FG)

dietary surveillance and conventional therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control Group (CG)

deworming and WHO diet

Group Type: ACTIVE_COMPARATOR

deworming

Intervention Type: OTHER

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

recommended diet

Intervention Type: OTHER

WHO Diet

Intervention Group (IG)

deworming and the Nutritional Support System (NSS)

Group Type: EXPERIMENTAL

Nutritional Support System (NSS)

Intervention Type: DIETARY_SUPPLEMENT

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

deworming

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

deworming

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

Intervention Type: OTHER

recommended diet

WHO Diet

Intervention Type: OTHER

Other Intervention Names

Intervention treatment

Eligibility Criteria

Inclusion Criteria

• Patients with CP with spastic diparesia and GMFCS III
• Re-entry
• Presence and support of a full-time caregiver
• To tolerate oral feeding
• Parents or guardians agree in writing to participate in the project
• Patients treated at the CRIT of Tlalnepantla Edo. Mex
• That the children, in the case of being able to write, accept in writing to participate in the project

Exclusion Criteria

• Presence of any other catabolic disease, which further increases the risk of malnutrition (renal, cardiovascular, pulmonary, hepatic, immunological)
• Have had infectious problems or have received antibiotic treatment 15 days prior to the start of the study.
• Have received botulinum toxin therapy in the last 4 months
• Muscle relaxants in the last 6 months
• Severe gastroesophageal reflux
• Patients with any type of surgery performed with a period shorter than 9 months
• That can walk by themselves

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anahuac University

OTHER

Sponsor Role: lead

Responsible Party

Fernando Leal-Martinez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando Leal

Role: STUDY_DIRECTOR

Universidad Anáhuac Norte

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2014/03001

Identifier Type: -

Identifier Source: org_study_id