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

NCT ID: NCT02747381

Last Updated: 2016-04-21

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

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention

receive Alfacalcidol 1 mcg daily for 4 months beside the conventional asthma medications

Group Type EXPERIMENTAL

Alfacalcidol

Intervention Type DIETARY_SUPPLEMENT

1-alpha hydroxy cholecalciferol 1 mcg

control

Asthmatic patients receiving conventional asthma medications

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alfacalcidol

1-alpha hydroxy cholecalciferol 1 mcg

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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One alpha

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amani Mohamed

Teaching assisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amani Ali

Role: PRINCIPAL_INVESTIGATOR

Faculty of pharmacy, Cairo university

References

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Ali AM, Selim S, Abbassi MM, Sabry NA. Effect of alfacalcidol on the pulmonary function of adult asthmatic patients: A randomized trial. Ann Allergy Asthma Immunol. 2017 May;118(5):557-563. doi: 10.1016/j.anai.2017.02.014. Epub 2017 Apr 1.

Reference Type DERIVED
PMID: 28377173 (View on PubMed)

Other Identifiers

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CL (1122)

Identifier Type: -

Identifier Source: org_study_id

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