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

Tanta University60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma in Children

Interventions

Modified Specific carbohydrate diet for 3 monthsDIETARY_SUPPLEMENT

All children at the start of the study will be subjected to: 1. Full history taking including demographic and medical history 2. Full nutritional assessment including: Through clinical examination for any signs of vitamins and mineral deficiency, with full chest examination. 3. Laboratory tests: Complete blood picture with differential white blood cells, and Serum IgE level 4. At the beginning of the study and at the end 1. The patients will be assessed using the childhood-asthma control test (C-ACT) as a subjective method 2. 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. 3. Anthropometric measurements: Weight, Height, and Body mass index (BMI). All measures will be plotted on specific percentile curves for age and Z score

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Baseline (three months)

Secondary Outcomes

FEV1

Will be performed using spirometry (Spirostik, Geratherm) to measure forced expiratory volume at the end of the first second.

Time frame: three months

FVC

Will be performed using spirometry (Spirostik, Geratherm) to measure forced vital capacity.

Time frame: 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.

Time frame: three months

Central Contacts

Rehab Z Elmeazawy, MD

CONTACT

01004815280 rehab.elmeazawy@med.tanta.edu.eg

Amany M Elbarky, MD

CONTACT

01065658386 amanyelbarky83@gmail.com

Data from ClinicalTrials.gov

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