Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202002786256542 Date of Approval: 12/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Vitamin D Supplementation on Recurrent episodes of Acute Otitis Media among Under Five Children in Alexandria: Randomized Control Study
Official scientific title Efficacy of Vitamin D Supplementation on Recurrent episodes of Acute Otitis Media among Under Five Children in Alexandria: Randomized Control Study
Brief summary describing the background and objectives of the trial Recurrent AOM is defined as 3 or more well-documented separate AOM episodes in the past 6 months or 4 or more episodes in the past 12 months with one or more episode in the past 6 months. The endocrine society recommends 400 IU/day for all children aged from zero up to one year and 600 IU/day for children aged 1 up to 18 years. The recommended upper limits for long term vitamin D intake are 1000 IU/day for children younger than 1 year old and 2000 IU/ day for older children and adults. Vitamin D hypoviatminosis is common in children with recurrent AOM so administration of vitamin D in a dose of 1000 IU/d restores serum values more than 30 ng/ml in most cases and it is associated with significant reduction in the risk of uncomplicated AOM irrespective of vitamin D serum levels . General objective: Efficacy of vitamin D supplementation on recurrent episodes of acute otitis media among under five children in Alexandria. Specific objectives: 1) To measure the level of vitamin D among the studied sample. 2) To identify the characteristic features of children with recurrent episodes of acute otitis media. 3) To study the efficacy of vitamin D supplementation on frequency of recurrent episodes of acute otitis media among under five children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/05/2020
Actual trial start date
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vitamin d supplementation 1000 I/U per day once daily 4 months vitamin d supplementation will be given in a dose of 1000 iu/day for 4 months among under 5 children suffering from recurrent episodes of acute otitis media 50
Control Group oral glucose supplementation 10 drops/ day 4 months oral glucose will be supplemented in a dose of 10 drops /day for a period of 4 month among under 5 children suffering from recurrent episodes of acute otitis media 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Under 5 children. 2. More than 3 well-documented separate AOM episodes in the past 6 months or more than 4 episodes in the past 12 months with more than 1 episode in the past 6 months 1. Craniofacial abnormalities (cleft palate). 2. Chronic disease (renal failure, diabetes, rickets, etc…). 3. Immunodeficiency (corticosteroid therapy, radiation therapy). 4. Adenoid hypertrophy Infant: 0 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year 0 Month(s) 5 Year(s) Both
1. Under 5 children. 2. More than 3 well-documented separate AOM episodes in the past 6 months or more than 4 episodes in the past 12 months with more than 1 episode in the past 6 months 1. Craniofacial abnormalities (cleft palate). 2. Chronic disease (renal failure, diabetes, rickets, etc…). 3. Immunodeficiency (corticosteroid therapy, radiation therapy). 4. Adenoid hypertrophy Infant: 0 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year 0 Month(s) 5 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 30/04/2020 Institutional Review Board High Institute of Public Health
Ethics Committee Address
Street address City Postal code Country
165 El-Horreya Avenue El-Ibrahimia alexandria 21500 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 1) To measure the level of vitamin D among the studied sample. 2) To identify the characteristic features of children with recurrent episodes of acute otitis media beginning of the study
Primary Outcome Efficacy of vitamin D supplementation on recurrent episodes of acute otitis media among under five children in Alexandria. end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
E.N.T clinic in the Main University Hospital Champollion Street El-Khartoum Square Azarita Medical Campus Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hazem Raafat Mohie ELdin Ibrahim 37 el fath street FLEMING alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor hazem hamad 37 el fath street alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Reham Abdel Haleem clinical pathologist 9 El Galaa street Victoria Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hazem hamd hazemhamad85@gmail.com 01280002440 37 el fath street
City Postal code Country Position/Affiliation
alexandria Egypt not affiliated
Role Name Email Phone Street address
Scientific Enquiries hamdy abouzeid abouzeid_hamdy@yahoo.com 01205496814 abd el hamid el abaady street roushdy
City Postal code Country Position/Affiliation
alexandria Egypt high institute of public health department of family health
Role Name Email Phone Street address
Public Enquiries Hanan Abd El Aziz Hmourad@alexu.edu.eg 01063686722 abd elsalam aref street saba basha
City Postal code Country Position/Affiliation
alexandria Egypt high institute of public health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes age and sex of the child, residence, family size, parent education and occupation, housing condition, family income Study Protocol available at 06/2021 open access high institute of public health will decide process for requesting data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information