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Impact of Modified Specific Carbohydrate Diet on Bronchial Asthma Control in Children

Primary Purpose

Asthma in Children

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified Specific carbohydrate diet for 3 months
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children focused on measuring Asthma, Children, Dietary therapy, Specific carbohydrate diet

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Asthmatic children with moderate persistent asthma according to the definition of National Heart, Lung, and Blood Institute guidelines, if they have daily symptoms, nighttime awakenings more than 1 time/week, but not nightly, daily use of short-acting beta-agonist for symptom control, some limitations of normal activities, and Forced Expiratory Volume in 1 second (FEV1)60-80%. Children aged from 6 to 18 years. The children are included only if parents and children are strongly motivated to try a dietary intervention (mSCD) as a complementary treatment. Exclusion Criteria: Children with chronic lung disease, immunodeficiency, major thoracic deformities, neuromuscular, cardiovascular, digestive, rheumatic, osteoarticular, or genetic syndromes or any adverse health conditions that can affect nutritional status were excluded from the study. Children excluded if parents and children are not motivated to try a dietary intervention (mSCD) as a complementary treatment or who failed to have regular outpatient follow-up visits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Modified SPD as adjunct to asthma medications in children

    Usual asthma medications only in children with moderate asthma

    Arm Description

    Explore if the modified specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them.

    Assess control based on the usual asthma medications only

    Outcomes

    Primary Outcome Measures

    Childhood-asthma control test (C-ACT) as a subjective method
    The C-ACT consists of a 7-item validated questionnaire, addresses the previous 4 weeks and is divided into two parts. One part is filled in by the child and consists of four questions on perception of asthma control, limitation of activities, coughing and awakenings at night. Each question has four response options. The second part is filled in by the parent or caregiver and consists of three questions (daytime complaints, daytime wheezing and awakenings at night) with six response options. The sum of all scores yields the C-ACT score, ranging from 0 (poorest asthma control) to 27 (optimal asthma control). A cut-off point ≤ 19indicates uncontrolled asthma

    Secondary Outcome Measures

    FEV1
    Will be performed using spirometry (Spirostik, Geratherm) to measure forced expiratory volume at the end of the first second.
    FVC
    Will be performed using spirometry (Spirostik, Geratherm) to measure forced vital capacity.
    FEV1/FVC ratio
    Will be performed using spirometry (Spirostik, Geratherm) to measure the ratio of forced expiratory volume at the end of first second to the forced vital capacity.

    Full Information

    First Posted
    January 10, 2023
    Last Updated
    July 13, 2023
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05728385
    Brief Title
    Impact of Modified Specific Carbohydrate Diet on Bronchial Asthma Control in Children
    Official Title
    Impact of Modified Specific Carbohydrate Diet on Bronchial Asthma Control in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    January 31, 2024 (Anticipated)
    Study Completion Date
    March 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study will explore if the specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them.
    Detailed Description
    This study will be carried out on 30 children with moderate persistent asthma presented to the outpatient clinic of the Pulmonology Unit, Pediatric Department, Tanta University Hospital. All children at the start of the study will be subjected to full history taking including, full nutritional assessment, laboratory tests, Pulmonary function tests, and Anthropometric measurements

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma in Children
    Keywords
    Asthma, Children, Dietary therapy, Specific carbohydrate diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified SPD as adjunct to asthma medications in children
    Arm Type
    Experimental
    Arm Description
    Explore if the modified specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them.
    Arm Title
    Usual asthma medications only in children with moderate asthma
    Arm Type
    No Intervention
    Arm Description
    Assess control based on the usual asthma medications only
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Modified Specific carbohydrate diet for 3 months
    Intervention Description
    All children at the start of the study will be subjected to: Full history taking including demographic and medical history Full nutritional assessment including: Through clinical examination for any signs of vitamins and mineral deficiency, with full chest examination. Laboratory tests: Complete blood picture with differential white blood cells, and Serum IgE level At the beginning of the study and at the end The patients will be assessed using the childhood-asthma control test (C-ACT) as a subjective method Pulmonary function tests will be performed using spirometry (Spirostik, Geratherm) that includes Forced vital capacity (FVC), forced expiratory volume in the first second of FVC (FEV1), and FEV1/FVC. Anthropometric measurements: Weight, Height, and Body mass index (BMI). All measures will be plotted on specific percentile curves for age and Z score
    Primary Outcome Measure Information:
    Title
    Childhood-asthma control test (C-ACT) as a subjective method
    Description
    The C-ACT consists of a 7-item validated questionnaire, addresses the previous 4 weeks and is divided into two parts. One part is filled in by the child and consists of four questions on perception of asthma control, limitation of activities, coughing and awakenings at night. Each question has four response options. The second part is filled in by the parent or caregiver and consists of three questions (daytime complaints, daytime wheezing and awakenings at night) with six response options. The sum of all scores yields the C-ACT score, ranging from 0 (poorest asthma control) to 27 (optimal asthma control). A cut-off point ≤ 19indicates uncontrolled asthma
    Time Frame
    Baseline (three months)
    Secondary Outcome Measure Information:
    Title
    FEV1
    Description
    Will be performed using spirometry (Spirostik, Geratherm) to measure forced expiratory volume at the end of the first second.
    Time Frame
    three months
    Title
    FVC
    Description
    Will be performed using spirometry (Spirostik, Geratherm) to measure forced vital capacity.
    Time Frame
    three months
    Title
    FEV1/FVC ratio
    Description
    Will be performed using spirometry (Spirostik, Geratherm) to measure the ratio of forced expiratory volume at the end of first second to the forced vital capacity.
    Time Frame
    three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Asthmatic children with moderate persistent asthma according to the definition of National Heart, Lung, and Blood Institute guidelines, if they have daily symptoms, nighttime awakenings more than 1 time/week, but not nightly, daily use of short-acting beta-agonist for symptom control, some limitations of normal activities, and Forced Expiratory Volume in 1 second (FEV1)60-80%. Children aged from 6 to 18 years. The children are included only if parents and children are strongly motivated to try a dietary intervention (mSCD) as a complementary treatment. Exclusion Criteria: Children with chronic lung disease, immunodeficiency, major thoracic deformities, neuromuscular, cardiovascular, digestive, rheumatic, osteoarticular, or genetic syndromes or any adverse health conditions that can affect nutritional status were excluded from the study. Children excluded if parents and children are not motivated to try a dietary intervention (mSCD) as a complementary treatment or who failed to have regular outpatient follow-up visits.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rehab Z Elmeazawy, MD
    Phone
    01004815280
    Email
    rehab.elmeazawy@med.tanta.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amany M Elbarky, MD
    Phone
    01065658386
    Email
    amanyelbarky83@gmail.com

    12. IPD Sharing Statement

    Citations:
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    34718211
    Citation
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