Nutrition Disorder, ChildNutrilectNCT06065904
Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD
A study testing Nutrilect in people with Nutrition Disorder, Child, run by Silviya Pavlova Nikolova, PhD.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Nutrition Disorder, Child
- What is being tested?
- Nutrilect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 30 Jul 2026
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Exploring the Efficacy of a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD: A Randomized Controlled Trial at a Single Center
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.
- Conditions
- Nutrition Disorder, Child
- Being tested
- Nutrilect
- 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.
NutrilectBehavioural
This intervention involves a comprehensive approach that includes a thorough nutritional assessment and individualized nutrition plan for children with cerebral palsy (CP) and Autism Spectrum Disorder (ASD), addressing their unique dietary needs and challenges. It encompasses nutritional counseling, dietary modifications when necessary, and seamless integration with other therapies, including speech therapy and psychological consultation. The overarching goal is to optimize growth, muscle function, and overall well-being in these children by providing tailored nutritional support alongside a holistic care approach.
| Study group | Role | What they receive |
|---|---|---|
| CP with recommended diet | Experimental | CP children that will follow a recommended menu Receives: Behavioral: Nutrilect |
| CP with a standard of care nutritional menu | No intervention | Children with CP that will not be advised on a specific menu |
| ASD with recommended diet | Experimental | Children with ASD that will not be advised on a specific menu Receives: Behavioral: Nutrilect |
| ASD with a standard of care nutritional menu | No intervention | Children with ASD that will not be advised on a specific menu |
What is being measured
The primary outcome is the main question the study is designed to answer.
bedridden days monthsmean duration of bedridden days over six months
mean duration of bedridden days
Measured: six months
Secondary outcomes (7)
Weight-for-Age Z-Score
The Weight-for-Age Z-Score serves as a secondary outcome measure in the study, primarily focusing on assessing changes in the study participants' weight status. Data collection involves anthropometric assessments and the utilization of reference growth charts, specifically the World Health Organization (WHO) reference charts, to record participants' weight relative to their age. This measurement employs the Z-score as the unit of measure, quantifying deviations in weight from the baseline. A positive Z-score indicates above-average weight for a given age group, while a negative Z-score indicates below-average weight, providing a valuable indicator of participants' nutritional status and growth trends over time.
Measured: six months
Height-for-Age Z-Score
The Height-for-Age Z-Score is a secondary outcome measure focused on evaluating changes in the study participants' height status. It involves anthropometric assessments and the use of WHO reference growth charts to record participants' height in relation to their age. The Z-score is the unit of measure, allowing for the quantification of height changes relative to the baseline. A positive Z-score indicates above-average height for the age group, while a negative Z-score indicates below-average height, offering a valuable indicator of participants' growth patterns and nutritional well-being over time.
Measured: six months
BMI-for-Age Z-Score
The secondary outcome measure, BMI-for-age Z-Score, assesses changes in the study participants' Body Mass Index (BMI) in relation to their age. This measurement relies on deriving BMI from weight and height measurements, with comparisons made using reference growth charts provided by the World Health Organization (WHO). The Z-score is employed as the unit of measure, enabling the quantification of BMI changes relative to the baseline. A positive Z-score signifies an above-average BMI for the age group, whereas a negative Z-score indicates a below-average BMI, serving as an essential metric for tracking variations in participants' nutritional status and body composition throughout the study.
Measured: six months
Number of social interactions per week with non-family members
The 'Number of Social Interactions per Week with Non-Family Members' is a quantitative measure that assesses the child's weekly engagement in social interactions with individuals outside their immediate family circle. It involves tracking and recording the frequency of diverse social exchanges, such as conversations, playdates, school-related interactions, and community engagements over a one-week period. This measure is instrumental in evaluating the child's social participation, integration into broader social networks, and overall quality of life. A higher number of interactions typically indicates greater social engagement and integration, while a lower number may signal reduced social participation, highlighting areas that require attention for the child's holistic development.
Measured: six months
Total Number of New Spoken Words per Month
Total Number of New Spoken Words per Month is a quantitative measure employed to evaluate a child's language development and communication skills over a one-month period. This measure involves systematically counting and recording the distinct words that the child effectively uses and articulates in conversations, interactions, or observations during the course of each month. Specifically, it focuses on identifying and tallying newly acquired words within the given timeframe.A higher number of newly spoken words typically indicates positive language development, reflecting effective vocabulary expansion and improved communication skills. A threshold of one new word per month is established as a meaningful indicator of progress.
Measured: six months
Total Days of School or Kindergarten Attendance per month
Total Days of School or Kindergarten Attendance per Month is a quantitative measure used to precisely assess a child's consistent participation in a formal educational setting, such as school or kindergarten, within the span of one month.A higher total number of days attended per month reflects more consistent participation in educational settings, indicating a stronger connection to learning opportunities and educational routines. Conversely, a lower total may indicate irregular attendance or potential challenges that require attention.
Measured: six month
Number of Leisure Activities per Month
The 'Number of Leisure Activities per Month' is a quantitative measure used to assess children's level of engagement in leisure and recreational pursuits over a one-month period. This measure involves systematically counting and documenting the quantity of diverse leisure activities, hobbies, or pastimes that the individual participates in during the designated month. Leisure activities encompass a wide range of choices, such as hobbies, sports, cultural events, or entertainment, selected for relaxation, enjoyment, and personal enrichment. A higher count of leisure activities often indicates a more diversified and active leisure lifestyle, potentially contributing to an enhanced overall quality of life, while a lower count may suggest limited engagement in leisure pursuits, highlighting opportunities for greater leisure satisfaction.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion23 Dec 2024 (estimated)
- Study completion30 Jul 2026 (estimated)
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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silviya Pavlova Nikolova, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor-investigator, Silviya Pavlova Nikolova, PhD, Medical University of Varna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065904
- Sponsor's protocol ID
- MUVarna
- Acronym
- Nutrilect
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy of a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD: A Randomized Controlled Trial at a Single Center
- ClinicalTrials.gov ID
- NCT06065904
- Acronym / sponsor ID
- Nutrilect / MUVarna
- Conditions
- Nutrition Disorder, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Silviya Pavlova Nikolova, PhDUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 23 Dec 2024 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 4 Oct 2023 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CP with recommended diet | Experimental | Behavioral: NutrilectCP children that will follow a recommended menu |
| CP with a standard of care nutritional menu | No intervention | –Children with CP that will not be advised on a specific menu |
| ASD with recommended diet | Experimental | Behavioral: NutrilectChildren with ASD that will not be advised on a specific menu |
| ASD with a standard of care nutritional menu | No intervention | –Children with ASD that will not be advised on a specific menu |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| NutrilectThis intervention involves a comprehensive approach that includes a thorough nutritional assessment and individualized nutrition plan for children with cerebral palsy (CP) and Autism Spectrum Disorder (ASD), addressing their unique dietary needs and challenges. It encompasses nutritional counseling, dietary modifications when necessary, and seamless integration with other therapies, including speech therapy and psychological consultation. The overarching goal is to optimize growth, muscle function, and overall well-being in these children by providing tailored nutritional support alongside a holistic care approach. | Behavioural | ASD with recommended diet, CP with recommended diet |
Primary outcome
bedridden days monthsmean duration of bedridden days over six months
Time frame: six months
mean duration of bedridden days
7 secondary outcomes
Weight-for-Age Z-Score
Time frame: six months
Height-for-Age Z-Score
Time frame: six months
BMI-for-Age Z-Score
Time frame: six months
Number of social interactions per week with non-family members
Time frame: six months
Total Number of New Spoken Words per Month
Time frame: six months
Total Days of School or Kindergarten Attendance per month
Time frame: six month
Number of Leisure Activities per Month
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrilect in people with Nutrition Disorder, Child, run by Silviya Pavlova Nikolova, PhD.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. 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?
Results are not available in the source record.
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?
bedridden days monthsmean duration of bedridden days over six months (time frame: six months). 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 4 Oct 2023.