Nutrition Disorder, ChildENSSIGMCPNCT03933709
Effect of a Nutritional Support System for Improving Gross Motor Function in Cerebral Palsy
A study testing Nutritional Support System (NSS), deworming and recommended diet in people with Nutrition Disorder, Child and Gross Motor Development Delay, run by Anahuac University.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Nutrition Disorder, Child, Gross Motor Development Delay, Neuro: Cerebral Palsy
- What is being tested?
- Nutritional Support System (NSS), deworming and recommended diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2015to 7 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: CONTROLLED, RANDOMIZED, BLIND CLINICAL TRIAL OF EFFECT OF A NUTRITIONAL SUPPORT SYSTEM (DIET, SUPPLEMENTS AND PROBIOTIC) FOR IMPROVING GROSS MOTOR FUNCTION IN CEREBRAL PALSY
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
- Being tested
- Nutritional Support System (NSS), deworming, recommended diet
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Support System (NSS)Dietary supplement
Also called Intervention treatment
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
dewormingOther
nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days.
recommended dietOther
WHO Diet
| Study group | Role | What they receive |
|---|---|---|
| Follow-up Group (FG) | No intervention | dietary surveillance and conventional therapy |
| Control Group (CG) | Active comparator | deworming and WHO diet Receives: Other: deworming; Other: recommended diet |
| Intervention Group (IG) | Experimental | deworming and the Nutritional Support System (NSS) Receives: Dietary Supplement: Nutritional Support System (NSS); Other: deworming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Gross Motor function Measure at 7 and 13 weeks
This scale assesses five general parameters:
- Lying (decubitus) and rolling over (GMFAV),
- Sitting (GMFB),
- Crawling and kneeling (GMFC),
- Standing (GMFD),
- Walking (GMFE) and one final total item (GMFF).
The scoring system consists of 88 items and each one is valued based on the following criteria:
0= No,
- start,
- Partially Complete,
- Complete, NE= Not evaluated
Measured: The GMFM scale was performed at baseline time and weeks 7 and 13 after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start12 Jan 2015
- Primary completion18 Dec 2015
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Disorder, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anahuac University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Leal-Martinez, Anahuac University
- Investigators
- Fernando Leal, Study director, Universidad Anáhuac Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933709
- Sponsor's protocol ID
- 2014/03001
- Other IDs
- 2014
- Acronym
- ENSSIGMCP
- Status last verified
- Apr 2019
- First submitted
- 20 Mar 2019
- Last updated
- 1 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONTROLLED, RANDOMIZED, BLIND CLINICAL TRIAL OF EFFECT OF A NUTRITIONAL SUPPORT SYSTEM (DIET, SUPPLEMENTS AND PROBIOTIC) FOR IMPROVING GROSS MOTOR FUNCTION IN CEREBRAL PALSY
- ClinicalTrials.gov ID
- NCT03933709
- Acronym / sponsor ID
- ENSSIGMCP / 2014/03001
- Conditions
- Nutrition Disorder, Child, Gross Motor Development Delay, Neuro: Cerebral Palsy, Diet Modification, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Anahuac UniversityUniversity, hospital or other
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Exploratory Study
| Arm | Type | Receives |
|---|---|---|
| Follow-up Group (FG) | No intervention | –dietary surveillance and conventional therapy |
| Control Group (CG) | Active comparator | Other: deworming, Other: recommended dietdeworming and WHO diet |
| Intervention Group (IG) | Experimental | Dietary Supplement: Nutritional Support System (NSS), Other: dewormingdeworming and the Nutritional Support System (NSS) |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Support System (NSS)Also: Intervention treatmentEnvelope 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 | Dietary supplement | Intervention Group (IG) |
| dewormingnitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days. | Other | Control Group (CG), Intervention Group (IG) |
| recommended dietWHO Diet | Other | Control Group (CG) |
Primary outcome
Change from Gross Motor function Measure at 7 and 13 weeks
Time frame: The GMFM scale was performed at baseline time and weeks 7 and 13 after intervention.
This scale assesses five general parameters: 1. Lying (decubitus) and rolling over (GMFAV), 2. Sitting (GMFB), 3. Crawling and kneeling (GMFC), 4. Standing (GMFD), 5. Walking (GMFE) and one final total item (GMFF). The scoring system consists of 88 items and each one is valued based on the following criteria: 0= No, 1. start, 2. Partially Complete, 3. Complete, NE= Not evaluated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Leal study director
Universidad Anáhuac Norte
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Support System (NSS), deworming and recommended diet in people with Nutrition Disorder, Child and Gross Motor Development Delay, run by Anahuac University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Gross Motor function Measure at 7 and 13 weeks (time frame: The GMFM scale was performed at baseline time and weeks 7 and 13 after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.