The comparison of the effect of Zinc and Vitamin D supplementation on Acute Bronchiolitis
Design
In this research, 135 eligible patients suffering from Acute Bronchiolitis were chosen purposefully. Then, patients were randomly divided into control and intervention groups.
Settings and conduct
In this double blind research,135 children who are at the age of 2 to 23 months and who are admitted in Mousavi Hospital in Zanjan with the diagnosis of Acute Bronchiolitis will be chosen randomly. These children will be divided into three blind groups and they will evaluate blindly. First group takes Zinc, second takes Vitamin D, and third takes no supplement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age under 2 years old; The first wheezing attack with respiratory infection; Pulse Rate less than 180; Respiratory Rate less than 100
Exclusion criteria: Use of supplementary more than routine; Previous wheezing or use of bronchodilator; Prematurity Cardiopulmonary disease; Aspiration; Neuromuscular disease; Immune deficiency; Need for mechanical ventilation; Previous use of corticostroid in 2 last weeks; Intolerancy or cuasing side effects after using the medicine
Intervention groups
In three groups; First group takes Hypertonic Salin and Zinc Sulfate(20 mg) every day for a week, Second group takes HypertonicSalin and Vitamin D(100 unit per kg)every day for a week, And third group just takes Hypertonic Salin.
Main outcome variables
Studing of the duration of fever; Staying in the hospital; Respiratory distress; Respiratory rate; Wheezing; Saturation of oxygen; And granting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131217015835N7
Registration date:2018-05-17, 1397/02/27
Registration timing:registered_while_recruiting
Last update:2018-05-17, 1397/02/27
Update count:0
Registration date
2018-05-17, 1397/02/27
Registrant information
Name
Parisa Khoshnevisasl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 1427 2737
Email address
khoshnevis@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
zanjan university of medical sciences ,vice chancellor for research
Expected recruitment start date
2017-09-27, 1396/07/05
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Zinc and Vitamin D supplementation on Acute Bronchiolitis in 2 to 23 months old children, a clinical trial
Public title
Comparison of the effect of Zinc and Vitamin D supplementation on Acute Bronchiolitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age under 2 years old
The first wheezing attack with respiratory infection
Pulse Rate less than 180
Respiratory Rate less than 100
Exclusion criteria:
Use of supplementary more than routine
Previous wheezing or use of bronchodilator
Prematurity
Cardiopulmonary disease
Aspiration
Neuromuscular disease
Immune deficiency
Need for mechanical ventilation
Previous use of corticostroid in 2 last weeks
Intolerancy or cuasing side effects after using the medicine
Age
From 2 months old to 23 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization is chosen. Random number table is used. We will use numbers from 1 to 135 in this table and we will read these numbers from up to down and we will write the succession. Then we will give Vitamin D to numbers 1 to 45 and Zinc to numbers 46 to 90 and no drugs to numbers 91 to 135. Then for allocation concealment we will use sequentially numbered, sealed, opaque envelopes. Every one who will enter our study will chose one envelope which has one number of the table in it and the group will be chosen for that person.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this trial participants and the outcome evaluators are blind. Participants know that they take supplements besides routine drugs but instead of the name of the supplements we use codes. The evaluators evaluate the outcomes according to the codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics commite of zanjan university of medical sciences
Street address
zanjan university of medical sciences ,azadi square
City
Zanjan
Province
Zanjan
Postal code
45154
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
zums.rec.1396.50
Health conditions studied
1
Description of health condition studied
Acute bronchiolitis
ICD-10 code
J21.9
ICD-10 code description
Acute bronchiolitis, unspecified
Primary outcomes
1
Description
wheezing
Timepoint
first day,third day,and seventh day in the hospital
Method of measurement
using stethoscope
2
Description
respiratory rate
Timepoint
first day,third day,and seventh day in the hospital
Method of measurement
counting of chest movements
Secondary outcomes
1
Description
the duration of staying in the hospital
Timepoint
first day,third day,seventh day
Method of measurement
counting the days of staying in the hospital
2
Description
the duration of fever
Timepoint
first day,third day,seventh day
Method of measurement
thermometer
3
Description
percent of arterial saturation of oxygen
Timepoint
first day,third day,seventh day
Method of measurement
pulseoxymeter
4
Description
the duration of existence of cough
Timepoint
first day,third day.seventh day
Method of measurement
asking from the patient
5
Description
side effects of drugs
Timepoint
first day,third day,seventh day
Method of measurement
asking from the patient and physical examination
6
Description
the duration of cyanosis
Timepoint
first day,third day,seventh day
Method of measurement
observe the color of skin
7
Description
the duration of respiratoty distress
Timepoint
first day,third day,seventh day
Method of measurement
observe useing of respiratory muscles which are not the main ones
8
Description
the duration of dehydration
Timepoint
first day,third day,seventh day
Method of measurement
amount of urine out put and mucusal dryness and skin turgor
Intervention groups
1
Description
Intervention group: First group takes 2 mg/kg/day(max 20 mg) syrup Zinc Sulfate10 of Alhavy Company for 1 week or during hospitalization if the days of admission are less than 1 week.
Category
Treatment - Drugs
2
Description
Intervention group: Second group takes 100 unit per kg per day drop Vitamin D (1000 IU in 1 ml) of Vitabiotic company for 1 week or during hospitalization if the days of admission are less than 1 week.
Category
Treatment - Drugs
3
Description
Control group: Third group does not take any supplements.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Musavi Hospital
Full name of responsible person
Dr. Parisa Khoshnevis Asl(pediatrics specialist)
Street address
Musavi Hospital, Gavazan Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor of Research and Technology, Zanjan University of Medical Sciences (Primary sponsor)
Full name of responsible person
Dr. Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45154
Phone
+98 24 3342 0651
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor of Research and Technology, Zanjan University of Medical Sciences (Primary sponsor)