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NCT02747381 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02747381
Other study ID # CL (1122)
Secondary ID
Status Completed
Phase Phase 4
First received April 19, 2016
Last updated April 20, 2016
Start date August 2014
Est. completion date April 2016

Study information
Verified date April 2016
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date April 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 1a-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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Alfacalcidol
1-alpha hydroxy cholecalciferol 1 mcg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary forced expiratory volume % predicted values 4 months Yes
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