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

July 13, 2023 updated by: Rehab Zaki Elmeazawy, Tanta University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
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

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
No Intervention: Usual asthma medications only in children with moderate asthma
Assess control based on the usual asthma medications only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childhood-asthma control test (C-ACT) as a subjective method
Time Frame: 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
Baseline (three months)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mSCD in Asthmatic children

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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