Vitamin D Improves Clinical Manifestations in Asthmatic Children

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167617
• Other study ID #: 34960/10/21
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: December 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 15, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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