The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients

Phase 4

Completed

• Conditions: Asthma
• Interventions: Dietary Supplement: Alfacalcidol

• Registration Number: NCT02747381
• Lead Sponsor: Cairo University

Brief Summary

This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on the the pulmonary function of adult asthmatic Egyptian patients

Detailed Description

Asthmatic patients are recruited and divided into two groups. One receives Alfacalcidol beside their normal medications while the other acts as a control group receiving the normal asthma medication.

Both groups are followed up for four months.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2016-02
• Status Verified: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-21
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Patients diagnosed with asthma
2. Non-smokers

Exclusion Criteria

1. Liver impairment
2. Kidney impairment
3. Patients receiving digoxin
4. Known hypersensitivity to 1α-hydroxyvitamin D3, vitamin D or any of its analogues and derivatives
5. Hypercalcaemia
6. Hyperphosphatemia
7. Pregnancy and breast-feeding
8. Patients on nutritional supplements with a potential effect on 25(OH)D serum concentrations
9. Had a History of stones in the urinary tract or diseases of calcium or bone metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Alfacalcidol	receive Alfacalcidol 1 mcg daily for 4 months beside the conventional asthma medications

Primary Outcome Measures

Name	Time	Method
forced expiratory volume % predicted values	4 months