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Vitamin D Supplementation for Acute Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03799406
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Amal Osman, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: Cholecalciferol Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Oral Vitamin D Supplementation in Egyptian Infants With Acute Bronchiolitis Improve the Outcome? A Double Blind Randomized Controlled Trial
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Intervention group
cholecalciferol at dose of 100 IU/Kg/day
Drug: Cholecalciferol
Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis
Other Name: Vitamin D

Placebo Comparator: Placebo group
placebo
Other: Placebo
Placebo supplementation during acute episode of bronchiolitis




Primary Outcome Measures :
  1. length of hospital stay [ Time Frame: 3 to 5 days ]
    Length of hospital stay in days



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants aged 1-24 months of age, diagnosed clinically as acute bronchiolitis and presented with any of the following:

    1. Persistent resting oxygen saturation below 92% in room air.
    2. Marked tachypnea.
    3. Intercostal retractions indicating respiratory distress.
    4. Inability to maintain oral hydration.
    5. Parent unable to care for child at home.

Exclusion Criteria:

  1. Infants with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, and any other chronic medical condition.
  2. Patients receiving any micronutrient supplementation or therapies containing vitamin D for 4 weeks prior to the study period.
  3. Infants with previous episodes of wheezing or a physician's diagnosis of asthma.
  4. Patients with acute bronchiolitis having very severe clinical score.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799406


Locations
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Egypt
Mansoura University Children's Hospital
Mansourah, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: amal osman, M.D. Mansoura University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amal Osman, Lecturer of Pediatrics, Mansoura University, Mansoura University
ClinicalTrials.gov Identifier: NCT03799406    
Other Study ID Numbers: MS/16.01.38
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Amal Osman, Mansoura University:
Acute bronchiolitis
Vitamin D
Modified Tal score
Randomized
Controlled trial
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Respiratory Tract Infections
Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents