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EFFECTS OF THE VITAMIN D ADMINISTRATION ON RESPIRATORY FUNCTIONS IN PAEDIATRIC PATIENTS SUFFERING FROM EFFORT ASTHMA -

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000762-35-IT

Enrollment

Registered

2011-12-23

Start date

2011-11-18

Completion date

Unknown

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paediatric patients suffering from effort asthma MedDRA version: 14.1 Level: LLT Classification code 10003558 Term: Asthma extrinsic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: DIBASE*IM OS 6F 1ML 100000UI/M Pharmaceutical Form: Oral solution INN or Proposed INN: VITAMIN D NOS CAS Number: 8000055643 Concentration unit: IU/ml international unit(s)/millilitre Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Paediatric patients (male and female) with: - age between 6 and 14 years - symptomatology consistent with effort asthma - decrease of FEV1= 20% to effort asthma - short term ß2 agonist therapy, not intake during 12 hours before the test - perpetual allergenes sensitivity Are the trial subjects under 18? yes Number of subjects for this age range: 23 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - children treated with long term ß2 agonist therapy in the last 3 months - antileucotrienic drugs intake in the last month - systemic and inhaled corticosteroid therapy in the last 3 months - VitD supplements in the last year - intake of short term ß2 agonist therapy during 12 hours before the test - seasonal allergenes sensitivity during the season of highest allergene concentration and chronic inflammatory disease

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is evaluates the vitamin D administration’s effect on respiratory function in paediatric patients with a symptomatology consistent with effort asthma and a ?FEV1= 20% to effeort test;Secondary Objective: To dose cells producing IL-10 and IL-17 and pulmonary levels, estimated on sputum, and on the serum surfactant protein D;Primary end point(s): Improvement in effort test with an increase of 10% at least in treated patients;Timepoint(s) of evaluation of this end point: nd	—

Measure

Time frame

Main Objective: The objective of the study is evaluates the vitamin D administration’s effect on respiratory function in paediatric patients with a symptomatology consistent with effort asthma and a ?FEV1= 20% to effeort test;Secondary Objective: To dose cells producing IL-10 and IL-17 and pulmonary levels, estimated on sputum, and on the serum surfactant protein D;Primary end point(s): Improvement in effort test with an increase of 10% at least in treated patients;Timepoint(s) of evaluation of this end point: nd

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Secondary

Measure	Time frame
Secondary end point(s): nd;Timepoint(s) of evaluation of this end point: nd	—

Countries

Italy

Contacts

Public ContactClinica Pediatrica

Azienda Ospedaliera Universitaria Integrata Verona

attilio.boner@univr.it045/8124615

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

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