Vitamin D Improves Clinical Manifestations in Asthmatic Children

Vitamin D Supplemental Therapy for Asthmatic Children May Improve Clinical Manifestations and Reduce IgE Serum Levels

Objectives: Evaluation of the effect of vitamin D supplemental therapy (VDST) on clinical manifestation of bronchial asthma (BA) as judged by The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire and estimated serum levels of immunoglobulin E (IgE).

Patients & Methods: scores of ISAAC questionnaire and blood samples were obtained for estimation of serum IgE and 25-hydroxy VD (25-HVD) at booking time (T1) of 102 BA patients. VDST was provided as 2000 IU daily for 3 and 6 months for patients had moderate and mild HVD, respectively. At the end of 12-m after start of VDST (T2), ISAAC questionnaire and serum levels of 25-HVD and IgE were re-evaluated and the percentage of change was calculated.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Drug: Vit D

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients in the age group of 6-14 years, free of exclusion criteria and complaining of chest wheezes were included in the study.

Exclusion Criteria:

• Presence of acute asthmatic attack, current or recurrent chest infection, allergic dermatological disorders, chronic rhino-sinusitis, deviated nasal septum, other nasal or palatal congenital anomalies, history of chronic exposure to allergens, or living in areas characterized by air pollution, being passive smokers since birth, presence of autoimmune disorders, serum 25-HVD >50 nmol/L and presence of clinically evident HVD.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin Deficiency	Drug: Vit D; Vit D was provided as 2000 IU daily for 3 and 6 months for patients who had mild and moderate HVD, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement	The effect of vitamin D supplemental therapy on pediatric asthma severity as judged by the score of ISSAC questionnaire.	3 to 6 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 34960/10/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No