Clinical trial NCT05728385: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma in Children
Keywords: Asthma
Children
Dietary therapy
Specific carbohydrate diet
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Childhood-asthma control test (C-ACT) as a subjective method
timeFrame: Baseline (three months)
Secondary outcomes:
measure: FEV1
timeFrame: three months
measure: FVC
timeFrame: three months
measure: FEV1/FVC ratio
timeFrame: three months
Other outcomes:
Locations:
Study officials:
References:
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