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Vitamin D Improves Clinical Manifestations in Asthmatic Children

Primary Purpose

Asthma in Children

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Vit D
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma in Children

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin Deficiency

Arm Description

Outcomes

Primary Outcome Measures

Clinical Improvement
The effect of vitamin D supplemental therapy on pediatric asthma severity as judged by the score of ISSAC questionnaire.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2021
Last Updated
December 9, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05167617
Brief Title
Vitamin D Improves Clinical Manifestations in Asthmatic Children
Official Title
Vitamin D Supplemental Therapy for Asthmatic Children May Improve Clinical Manifestations and Reduce IgE Serum Levels
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

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

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin Deficiency
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vit D
Intervention Description
Vit D was provided as 2000 IU daily for 3 and 6 months for patients who had mild and moderate HVD, respectively.
Primary Outcome Measure Information:
Title
Clinical Improvement
Description
The effect of vitamin D supplemental therapy on pediatric asthma severity as judged by the score of ISSAC questionnaire.
Time Frame
3 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tanta university
City
Tanta
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vitamin D Improves Clinical Manifestations in Asthmatic Children

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