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NCT05167617 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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