The object of this study was to determine the effect of oral zinc sulfate supplementation given with coamoxiclav as compared with coamoxiclav alone for treatment of otitis media with effusion (OME). The efficacy was assessed 3 and 6 weeks after administration.
In a double – blind, randomized trial a total of 52 children with OME who referred to ear, nose and throat clinic were randomly assigned into two groups.
Patients treated with coamoxiclav plus zinc sulfate syrup100 mg per 100ml, 10ml daily for 3 weeks in zinc group and placebo in control group. Treatment repeated for patients who have not been treated after 3 weeks(total of 6 weeks).Treatment were assessed by otoscopy and tympanometry in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809292893N1
Registration date:2007-03-20, 1385/12/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2007-03-20, 1385/12/29
Registrant information
Name
Poopak Izadi
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9437
Email address
izadi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2008-03-19, 1386/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
“Effect of oral supplementation of zinc on treatment of otitis media with effusion”
Public title
“Effect of oral supplementation of zinc on treatment of otitis media with effusion”
Purpose
Treatment
Inclusion/Exclusion criteria
Patients were excluded if they had any of the followings: ruptured tympanic membrane and otorrhea, a history of hypersensitivity to penicillin or zinc derivatives, antimicrobial treatment in the preceding 30 days, diseases such as sinusitis or pneumonia or anemia, recent episode of acute otitis media, previous adenoidectomy or ventilation tube insertion, compromised immunity or any pathology of the ear, nose and throat or factors that could preclude completion of treatment
Age
To 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Shahed University
Street address
Tehran qom highway, In front of holy shrine of Imam Khomeini
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
37824
Health conditions studied
1
Description of health condition studied
Otitis Media with effusion
ICD-10 code
H65.9, H65
ICD-10 code description
Nonsuppurative otitis media, unspecified
Primary outcomes
1
Description
Tympanic membrane status
Timepoint
baseline, 3 weeks, 6 weeks
Method of measurement
examination
Secondary outcomes
empty
Intervention groups
1
Description
Coamoxiclav suspension, 312, 5mg/5cc, 40mg/kg/day (TDS), oral + Placebo syrup, 10 ml daily, 3 and 6 weeks, oral