Vitamin D Supplementation for Acute Bronchiolitis

NCT03799406 | Completed Phase 2

• 1 other identifier: MS/16.01.38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Acute bronchiolitis; Vitamin D; Modified Tal score; Randomized; Controlled trial

Outcome Measures

Primary Outcomes (1)

• length of hospital stay

  Length of hospital stay in days

  3 to 5 days

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

cholecalciferol at dose of 100 IU/Kg/day

Drug: Cholecalciferol

Placebo group

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Cholecalciferol DRUG

Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis

Also known as: Vitamin D

Intervention group

Placebo OTHER

Placebo supplementation during acute episode of bronchiolitis

Placebo group

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Children's Hospital

Al Mansurah, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33305842 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• amal osman, M.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics, Mansoura University

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 10, 2019
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)