AsthmaPhase 4NCT02747381
The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients
A Phase 4 study testing Alfacalcidol in people with Asthma, run by Cairo University.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Alfacalcidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with asthma
- Non-smokers
Who cannot join
- Liver impairment
- Kidney impairment
- Patients receiving digoxin
- Known hypersensitivity to 1α-hydroxyvitamin D3, vitamin D or any of its analogues and derivatives
- Hypercalcaemia
- Hyperphosphatemia
Show all 9Show fewer
- Pregnancy and breast-feeding
- Patients on nutritional supplements with a potential effect on 25(OH)D serum concentrations
- Had a History of stones in the urinary tract or diseases of calcium or bone metabolism
About this study
This study evaluates the effect of vitamin D supplementation in the form of Alfacalcidol on the the pulmonary function of adult asthmatic Egyptian patients
Read the 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.
- Conditions
- Asthma
- Being tested
- Alfacalcidol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfacalcidolDietary supplement
Also called One alpha
1-alpha hydroxy cholecalciferol 1 mcg
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | receive Alfacalcidol 1 mcg daily for 4 months beside the conventional asthma medications Receives: Dietary Supplement: Alfacalcidol |
| control | No intervention | Asthmatic patients receiving conventional asthma medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced expiratory volume % predicted values
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startAug 2014
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Mohamed, Cairo University
- Investigators
- Amani Ali, Principal investigator, Faculty of pharmacy, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747381
- Sponsor's protocol ID
- CL (1122)
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28377173
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on the Pulmonary Functions of Adult Asthmatic Egyptian Patients
- ClinicalTrials.gov ID
- NCT02747381
- Acronym / sponsor ID
- CL (1122)
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Dietary Supplement: Alfacalcidolreceive Alfacalcidol 1 mcg daily for 4 months beside the conventional asthma medications |
| control | No intervention | –Asthmatic patients receiving conventional asthma medications |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with asthma
- Non-smokers
Key exclusion criteria (9 listed)
- Liver impairment
- Kidney impairment
- Patients receiving digoxin
- Known hypersensitivity to 1α-hydroxyvitamin D3, vitamin D or any of its analogues and derivatives
- Hypercalcaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfacalcidolAlso: One alpha1-alpha hydroxy cholecalciferol 1 mcg | Dietary supplement | intervention |
Primary outcome
forced expiratory volume % predicted values
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Derived from this study: PubMed 28377173Ali 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amani Ali principal investigator
Faculty of pharmacy, Cairo university
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfacalcidol in people with Asthma, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced expiratory volume % predicted values (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.