- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411901
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and non CF bronchiectasis pediatric patients.
Patients and Methods: This was a randomized clinical trial evaluating the role of oral vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Abbasia
-
Cairo, Abbasia, Egypt, 02
- Children Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ages less than 18 years .
- Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations).
- Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis .
- Vitamin D deficient or insufficient CF and non CF bronchiectasis patients
Exclusion Criteria: if they had
- sufficient Vitamin D level .
- chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases.
- reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: vitamin D 3
oral vitamin D3 drops and tablets
|
Theraputic vitamin D3 for CF and non CF bronchiectasis children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reach sufficient vitamin D level
Time Frame: 6 months
|
vitamin D more than 30 ng/dl
|
6 months
|
decrease disease severity
Time Frame: 6 months
|
decrease excerbations and increase lung function
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Bronchial Diseases
- Genetic Diseases, Inborn
- Pancreatic Diseases
- Bronchiectasis
- Cystic Fibrosis
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- Original study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cystic Fibrosis and Non CF Bronchiectasis
-
Children's Hospital Medical Center, CincinnatiRecruitingCystic Fibrosis | Non-CF BronchiectasisUnited States
-
Papworth Hospital NHS Foundation TrustLifeArcNot yet recruitingNon-cystic Fibrosis BronchiectasisUnited Kingdom
-
The University of Hong KongRecruiting
-
The University of Hong KongCompleted
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Assiut UniversityNot yet recruitingNon-cystic Fibrosis Bronchiectasis
-
Mayo ClinicRecruitingNon-cystic Fibrosis BronchiectasisUnited States
-
AstraZenecaActive, not recruitingNon-cystic Fibrosis BronchiectasisUnited States, Canada, Denmark, Germany, Italy, United Kingdom, Vietnam, China, Spain, Korea, Republic of, Argentina, Australia, Poland, Russian Federation, Philippines, India
-
Boehringer IngelheimCompletedNon-cystic Fibrosis BronchiectasisUnited Kingdom, Germany
-
All India Institute of Medical Sciences, New DelhiCompletedNon-cystic Fibrosis BronchiectasisIndia
Clinical Trials on Cholecalciferol (vitaminD3)
-
McGill UniversityTerminatedHealthy | Vitamin D Deficiency | Gestational DiabetesCanada
-
Medical University of South CarolinaTerminatedVitamin D Deficiency | Nutritional DeficiencyUnited States
-
Centre of Postgraduate Medical EducationUnknownInfant, Premature, DiseasesPoland
-
Johns Hopkins UniversityNational Institute on Aging (NIA)TerminatedVitamin D Deficiency | FallsUnited States
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)CompletedCystic Fibrosis | Allergic Bronchopulmonary AspergillosisUnited States
-
Rashid Centre for Diabetes and ResearchCompletedObesity | Type 2 Diabetes Mellitus | Hypovitaminosis DUnited Arab Emirates
-
University Hospitals Cleveland Medical CenterUniversity of Colorado, DenverCompletedInflammationUnited States
-
University Hospital, AngersMylan LaboratoriesCompleted
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted