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.: PACTR201704002162350 Date of Approval: 31/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vitamin D and irritable bowel syndrome in children
Official scientific title Vitamin D intervention in adolescents with irritable bowel syndrome
Brief summary describing the background and objectives of the trial There is growing interest in the role of vitamin D in pediatric chronic disorders and gut disorders e.g. irritable bowel syndrome (IBS). We aim to evaluate the effect of vitamin D supplementation in adolescents with IBS and normal vitamin D levels. This prospective double-blinded controlled trial will includ 150 adolescents with IBS and normal serum level of vitamin D, patients will be subdivided into 2 groups of matched age and sex. The first group will receive oral vitamin D3 1000 u/day for 6 months, the second group won¿t receive vitamin D. Vitamin D status will be evaluated at start, every 2 months and at the end of study, beside evaluation of different IBS score systems (IBS-SSS,IBS-QOL and total score). 100 healthy adolescents of matched age and sex will be taken as control group.
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 intervention
Anticipated trial start date 01/03/2014
Actual trial start date 06/04/2015
Anticipated date of last follow up 30/09/2016
Actual Last follow-up date 30/04/2017
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 112
Recruitment status Stopped early/ terminated
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 computer generated sealed opaque envelops Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vitamin D supplementation 1000 u/day 6 months giving vitamin D to children with irritable bowel syndrome with normal serum level of vitamin D 56 Active-Treatment of Control Group
Control Group nothing taken 6 months 56 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adolescent diagnosed with IBS depending on Rome III criteria for diagnosis of childhood irritable bowel syndrome with normal serum vitamin D level. 1- children with recent use of antibiotics (4 weeks) 2-recent change in IBS therapy, history of gut surgery or radiation, celiac disease 3-chronic drug therapy, children with body mass index (BMI) of less than 18 or more than 25 4-chronic disease such as renal failure or diabetes mellitus 5-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 06/01/2014 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 improvement of irritable bowel syndrome symptoms symptoms will be assessed at begining of treatment, every 2 month till the end of intervention (6 months).
Secondary Outcome serum level of vitamin D assessed before treatment then every 2 months for 6 months
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
none
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta university hospital elgeish tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Doaa El Amrousy elmotasem street Tanta 31522 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 31511 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries mohamed El Kashlan mohamedkashlan@yahoo.com +201222337746 mamoun street
City Postal code Country Position/Affiliation
tanta 31527 Egypt consultant
Role Name Email Phone Street address
Scientific Enquiries nagat Elshmaa nagat_elshmaa@yahoo.com +201211865637 elbendary street
City Postal code Country Position/Affiliation
tanta 31613 Egypt assistant professor
REPORTING
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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