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

April 20, 2016 updated by: Amani Mohamed, Cairo University
This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on the the pulmonary function of adult asthmatic Egyptian patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
receive Alfacalcidol 1 mcg daily for 4 months beside the conventional asthma medications
Dietary supplement: Alfacalcidol
1-alpha hydroxy cholecalciferol 1 mcg
Other Names:
  • One alpha
No Intervention: control
Asthmatic patients receiving conventional asthma medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
forced expiratory volume % predicted values
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Amani Ali, Faculty of Pharmacy, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL (1122)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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