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.: PACTR201712002835247 Date of Approval: 04/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Vitamin D and inflammatory bowel disease in children
Official scientific title Vitamin D supplementation in adolescents with inflammatory bowel disease: Does it work?
Brief summary describing the background and objectives of the trial Vitamin D deficiency found to be common in inflammatory bowel syndrome (IBD). There is growing interest in the role of vitamin D in pediatric IBD. We aim to evaluate the effect of vitamin D supplementation in children with IBD.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,IBD,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/12/2017
Actual trial start date 16/12/2017
Anticipated date of last follow up 15/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised random allocation software sealed opaque envelops Open-label(Masking Not Used) Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vitamin D supplementation 2000 IU/day 6 months oral treatment 60
Control Group placebo 2 droppe of glucose 5% 6 months oral treatment 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children with inflammatory bowel disease children with recent use of antibiotics (4 weeks), normal vitamin D level, recent change in IBS therapy, history of gut surgery or radiation, chronic drug therapy, children with body mass index (BMI) of more than 25, chronic disease such as renal failure or diabetes mellitus, patients taking vitamin D supplementation 5 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 03/12/2017 local ethical committee of faculty of medicine, Tanta University, Egypt
Ethics Committee Address
Street address City Postal code Country
El geish street tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to assess IBD symptoms and severity score after treatment with vitamin D for 6 months. before treatment after 3 months of treatment -after 6 months of treatment
Secondary Outcome correlation between serum vitamin D level and various clinical, radiological and laboratory variables after 3 months of treatment -after 6 months of treatmen
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 El mtasem 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 31511 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 El mtasem street Tanta 31522 Egypt
Samir Hassan el bahr street Tanta 31524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com +201278155283 el motasem street
City Postal code Country Position/Affiliation
tanta 31613 Egypt assistant professor of pediatric
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 Elkashlan mohamedkashlan@yahoo.com +201222337746 elmtasem street
City Postal code Country Position/Affiliation
tanta 31527 Egypt manager of hospital
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