NCT02747381

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

1.5 years

First QC Date

April 19, 2016

Last Update Submit

April 20, 2016

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • forced expiratory volume % predicted values

    4 months

Study Arms (2)

intervention

EXPERIMENTAL

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

Dietary Supplement: Alfacalcidol

control

NO INTERVENTION

Asthmatic patients receiving conventional asthma medications

Interventions

AlfacalcidolDIETARY_SUPPLEMENT

1-alpha hydroxy cholecalciferol 1 mcg

Also known as: One alpha
intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with asthma
  • Non-smokers

You may not qualify if:

  • Liver impairment
  • Kidney impairment
  • Patients receiving digoxin
  • Known hypersensitivity to 1α-hydroxyvitamin D3, vitamin D or any of its analogues and derivatives
  • Hypercalcaemia
  • Hyperphosphatemia
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28377173DERIVED

MeSH Terms

Conditions

Asthma

Interventions

alfacalcidolHydroxycholecalciferols

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Amani Ali

    Faculty of pharmacy, Cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assisstant

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 21, 2016

Study Start

August 1, 2014

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

April 21, 2016

Record last verified: 2016-04