Vitamin D Supplementation for Acute Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Acute bronchiolitis, Vitamin D, Modified Tal score, Randomized, Controlled trial
Eligibility Criteria
Inclusion Criteria:
Infants aged 1-24 months of age, diagnosed clinically as acute bronchiolitis and presented with any of the following:
- Persistent resting oxygen saturation below 92% in room air.
- Marked tachypnea.
- Intercostal retractions indicating respiratory distress.
- Inability to maintain oral hydration.
- Parent unable to care for child at home.
Exclusion Criteria:
- Infants with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, and any other chronic medical condition.
- Patients receiving any micronutrient supplementation or therapies containing vitamin D for 4 weeks prior to the study period.
- Infants with previous episodes of wheezing or a physician's diagnosis of asthma.
- Patients with acute bronchiolitis having very severe clinical score.
Sites / Locations
- Mansoura University Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention group
Placebo group
Arm Description
cholecalciferol at dose of 100 IU/Kg/day
placebo
Outcomes
Primary Outcome Measures
length of hospital stay
Length of hospital stay in days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03799406
Brief Title
Vitamin D Supplementation for Acute Bronchiolitis
Official Title
Does Oral Vitamin D Supplementation in Egyptian Infants With Acute Bronchiolitis Improve the Outcome? A Double Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study was conducted to evaluate the effect of oral vitamin D supplementation on the clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among infants who required hospital-based care for bronchiolitis is associated with the severity of the acute episode.
Detailed Description
This is a double blind randomized controlled trial which was conducted on 60 infants who required hospital-based care for acute bronchiolitis. The patients were recruited in the period from October 2018 to January 2019. Informed consents were obtained from all caregivers, and approved by Institutional Research Board of our University.
The diagnosis of acute bronchiolitis was based on a first episode of respiratory distress with wheezing and/ or crackles, preceded by an infection of the upper airways (rhinorrhea, coryza, cough, fever). Disease severity was evaluated using Modified-Tal scoring systems for bronchiolitis, since it is repeatable and can reliably be used in research and clinical practice
Sample size:
Our hospital data have shown that the mean LOS for cases admitted with acute bronchiolitis was 3 ± 2 days. Assuming a reduction in length of hospital stay by 50% and study power of 80% to detect a clinical significance (α error) of 0.05 between interventional groups, we calculated a sample size of 30 patients in each treatment group.
Randomization and Enrollment:
Patients were randomized to receive vitamin D3 treatment [100 IU/Kg/day in acute bronchiolitis] (vitamin D group) or placebo (placebo group) all through the period of admission as a previous cohort observational study has postulated that vitamin D daily dose close to 100 IU/kg body weight is favorable for infants up to age 12 months. Both groups were equal in number. Both vitamin D3 and placebo were in drop form and were identical in shape and nearly the same taste and color. The assignments were kept in sealed envelopes till data analysis. The randomization and allocation process were done by a higher nursing staff blinded to the study. Throughout the study, the medical staff, and parents were blind to assignments.
All patients were hospitalized and received treatment. The treatment consisted of intravenous fluids, oxygenation, and antipyretics if needed, and nebulized hypertonic saline. Nebulized adrenaline or salbutamol was added in severe cases according to the decision of a senior pediatrician. The validated clinical score for acute bronchiolitis were taken after a period of adjustment of at least 5 min and with the child quiet, not crying, without fever, and breathing room air. Respiratory rate were determined by observation of the thoracic movement over a full minute. The degree of accessory muscle use was based on the degree of intercostal or subcostal retraction. Physical examination as well as clinical severity score was recorded for each case at admission and every 12 hours, and at discharge. On discharge, all caregivers of breastfed, partially breastfed and bottle fed infants were advised to continue vitamin D supplementation at dose 400 IU per day
All patients were submitted to careful history taking, complete clinical examination and the following laboratory investigations.
Complete blood count
Basal serum vitamin D3 (The 25-hydroxy vitamin D): was done before enrollment of patients in the randomized trial.
Venous blood samples were collected from every subject by sterile venipuncture using disposable syringes. Each sample was then distributed as follows:
One ml of blood was disposed into a plastic tube containing EDTA solution for performing complete blood count using electronic cell counter (sysmex kx-21,Japon).
|Two ml blood was delivered into plain tube and centrifuged to obtain a clear non hemolyzed serum which was used for performing 25 (OH) vitamin D assays. The specimens were stored at - 20 until the time of the analysis. The serum 25 (OH) D levels were measured using the Enzyme-Linked Immunosorbent Assay (ELISA) method.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Acute bronchiolitis, Vitamin D, Modified Tal score, Randomized, Controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
cholecalciferol at dose of 100 IU/Kg/day
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D
Intervention Description
Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo supplementation during acute episode of bronchiolitis
Primary Outcome Measure Information:
Title
length of hospital stay
Description
Length of hospital stay in days
Time Frame
3 to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants aged 1-24 months of age, diagnosed clinically as acute bronchiolitis and presented with any of the following:
Persistent resting oxygen saturation below 92% in room air.
Marked tachypnea.
Intercostal retractions indicating respiratory distress.
Inability to maintain oral hydration.
Parent unable to care for child at home.
Exclusion Criteria:
Infants with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, and any other chronic medical condition.
Patients receiving any micronutrient supplementation or therapies containing vitamin D for 4 weeks prior to the study period.
Infants with previous episodes of wheezing or a physician's diagnosis of asthma.
Patients with acute bronchiolitis having very severe clinical score.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amal osman, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Children's Hospital
City
Mansourah
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33305842
Citation
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Results Reference
derived
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Vitamin D Supplementation for Acute Bronchiolitis
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