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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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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01864616 |
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Date of registration:
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22/05/2013 |
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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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The Impact of Vitamin D on Disease Activity in Crohn's Disease
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Scientific title:
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Date of first enrolment:
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July 2013 |
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Target sample size:
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9 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01864616 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Saudi Arabia
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Contacts
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Name:
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Hassanali Vatanparast, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Saskatchewan, Saskatoon, SK,Canada |
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Name:
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Dania Alrefai, M.Sc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Saskatchewan |
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Name:
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Wael El-matary, MBChB,MSc,MD,FRCPCH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manitoba |
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Name:
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Hani Jawa, MBBS,ABIM,FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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King Abdulaziz University, jeddah, Saudi Arabia |
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Name:
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Jennifer Jones, MD,MSc,FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal University Hospital, Saskatoon, Saskatchewan, Canada |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- newly diagnosis with an active Crohn's disease,
- age above of 16 years
Exclusion Criteria:
- remission or the duration of disease is more than 2 years,
- pregnancy,
- liver or kidney failure,
- inability to take oral supplements or medicine
Age minimum:
16 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Dietary Supplement: Vitamin D3
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Primary Outcome(s)
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The changes in disease activity on groups
[Time Frame: (0), 5 weeks, 9 weeks, after 2 months]
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Secondary Outcome(s)
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vitamin D status
[Time Frame: (0), Week 5, Week 9 (termination) and 2 months later]
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Health related quality of life
[Time Frame: (0), Week 5, Week 9 (termination) and 2 months later (follow up)]
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nutritional status
[Time Frame: 0, 5 weeks, 9 weeks, 2 months later]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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