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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201712002835247 |
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Date of registration:
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04/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Vitamin D and inflammatory bowel disease in children
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Scientific title:
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Vitamin D supplementation in adolescents with inflammatory bowel disease: Does it work? |
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Date of first enrolment:
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15/12/2017 |
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Target sample size:
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120 |
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Recruitment status: |
Other |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2835 |
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Study type:
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Interventional |
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Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,random allocation software,sealed opaque envelops
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Phase:
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Not Applicable
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mohamed
Elkashlan |
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Address:
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elmtasem street
31527
tanta
Egypt |
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Telephone:
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+201222337746 |
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Email:
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mohamedkashlan@yahoo.com |
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Affiliation:
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manager of hospital |
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Name:
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Nagat
Elshmaa |
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Address:
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elbendary street
31527
tanta
Egypt |
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Telephone:
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201211865637 |
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Email:
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nagat_elshmaa@yahoo.com |
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Affiliation:
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assistant professor |
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Key inclusion & exclusion criteria
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Inclusion criteria: children with inflammatory bowel disease
Exclusion criteria: 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
Age minimum:
5 Year(s)
Age maximum:
18 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Digestive System
Paediatrics
IBD
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Digestive System
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Paediatrics
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Intervention(s)
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placebo
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vitamin D supplementation
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Primary Outcome(s)
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to assess IBD symptoms and severity score after treatment with vitamin D for 6 months.
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Secondary Outcome(s)
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correlation between serum vitamin D level and various clinical, radiological and laboratory variables
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Source(s) of Monetary Support
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personal fund
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Ethics review
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Status: Approved
Approval date: 03/12/2017
Contact:
local ethical committee of faculty of medicine, Tanta University, Egypt
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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