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Vitamin D Improves Clinical Manifestations in Asthmatic Children

NCT ID: NCT05167617

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Vitamin Deficiency

Group Type EXPERIMENTAL

Vit D

Intervention Type DRUG

Vit D was provided as 2000 IU daily for 3 and 6 months for patients who had mild and moderate HVD, respectively.

Interventions

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Vit D

Vit D was provided as 2000 IU daily for 3 and 6 months for patients who had mild and moderate HVD, respectively.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed B.Hamza

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta university

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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34960/10/21

Identifier Type: -

Identifier Source: org_study_id