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.: PACTR201706002337124 Date of Approval: 04/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vitamin D supplementation in adolescents with irritable bowel syndrome: Is it useful?
Official scientific title Vitamin D supplementation in adolescents with irritable bowel syndrome: Is it useful?
Brief summary describing the background and objectives of the trial Vitamin D deficiency found to be common in irritable bowel syndrome (IBS). There is growing interest in the role of vitamin D in pediatric IBS. We aimed to evaluate the effect of vitamin D supplementation in adolescents with IBS and vitamin D deficiency.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,irritable bowel syndrome,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial vitamin D supplementation
Anticipated trial start date 01/04/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 30/04/2017
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 112
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised random allocation software sealed opaque envelops Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo 2 droppe of distilled water 6 months children with irritable bowel syndrome will recieve a placebo as 2 dropper of distilled water 56
Experimental Group vitamin D supplementation 2000 u/day 6 months adolescent with irritable bowel syndrome will recieve vitamin D supplementation for 6 months 56 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adolescent diagnosed with IBS and vitamin D deficiency depending on ROME III criteria for diagnosis of childhood irritable bowel syndrome children with recent use of antibiotics (4 weeks), normal vitamin D level, recent change in IBS therapy, history of gut surgery or radiation, celiac disease, chronic drug therapy, children with body mass index (BMI) of less than 18 or more than 25, chronic disease such as renal failure or diabetes mellitus, patients taking vitamin D supplementation 14 Year(s) 18 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
Yes 05/01/2015 ethics committee of faculty of medicine, tanta university
Ethics Committee Address
Street address City Postal code Country
elgeish street tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to assess IBS symptoms and severity score after treatment with vitamin D for 6 months. -after 3 months of treatment -after 6 months of treatment
Primary Outcome to assess IBS symptoms and severity score after treatment with vitamin D for 6 months. -before treatment after 3 months of treatment -after 6 months of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital El geish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal fund elmotasem street Tanta 31423 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Tanta university hospital El geish street Tanta 31522 Egypt Hospital
Primary Sponsor tanta university, faculty of medicine El geish street Tanta 31423 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Doaa El Amrousy elmotasem street Tanta 31522 Egypt
Samir Mahir el bahr street Tanta 31524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com +01278155283 elmtasem street
City Postal code Country Position/Affiliation
tanta 31613 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries nagat Elshmaa nagat_elshmaa@yahoo.com +201211865637 elbendary street
City Postal code Country Position/Affiliation
tanta 31527 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries mohamed El Kashlan mohamedkashlan@yahoo.com +201222337746 elmtasem street
City Postal code Country Position/Affiliation
tanta 31527 Egypt manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information