Impact of Modified Specific Carbohydrate Diet on Bronchial Asthma Control in Children
- Conditions
- Asthma in Children
- Interventions
- Dietary Supplement: Modified Specific carbohydrate diet for 3 months
- Registration Number
- NCT05728385
- Lead Sponsor
- Tanta University
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modified SPD as adjunct to asthma medications in children Modified Specific carbohydrate diet for 3 months 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.
- Primary Outcome Measures
Name Time Method Childhood-asthma control test (C-ACT) as a subjective method Baseline (three months) 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
Name Time Method FEV1/FVC ratio three months 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.
FEV1 three months Will be performed using spirometry (Spirostik, Geratherm) to measure forced expiratory volume at the end of the first second.
FVC three months Will be performed using spirometry (Spirostik, Geratherm) to measure forced vital capacity.