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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Asthma in Children

Intervention / Treatment
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* Dietary Supplement: Modified Specific carbohydrate diet for 3 months


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified SPD as adjunct to asthma medications in children<br>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. | Dietary Supplement: Modified Specific carbohydrate diet for 3 months<br>* 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<br>|
| No Intervention: Usual asthma medications only in children with moderate asthma<br>Assess control based on the usual asthma medications only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline (three months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Will be performed using spirometry (Spirostik, Geratherm) to measure forced expiratory volume at the end of the first second. | three months | 
| FVC | Will be performed using spirometry (Spirostik, Geratherm) to measure forced vital capacity. | three months | 
| 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. | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Children, Dietary therapy, Specific carbohydrate diet