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The Impact of Vitamin D on Disease Activity in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864616
Recruitment Status : Terminated (We couldn't recruit the sample the we required)
First Posted : May 29, 2013
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
Dania Alrefai
Dr.Jennifer Jones
Dr.Hani Jawa
Dr.Wael El-matary
Saudi Arabian Cultural Bureau
Information provided by (Responsible Party):
Hassanali Vatanparast, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE May 22, 2013
First Posted Date  ICMJE May 29, 2013
Last Update Posted Date May 14, 2018
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
The changes in disease activity on groups [ Time Frame: (0), 5 weeks, 9 weeks, after 2 months ]
We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up) To measure the disease activity, we will examine C- reactive protein levels "blood test", Fecal fat " stool test" and Crohn's disease activity index (CDAI)"tool".
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01864616 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
  • nutritional status [ Time Frame: 0, 5 weeks, 9 weeks, 2 months later ]
    We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up). We will use 24-hour dietary recalls for 9 different days.
  • vitamin D status [ Time Frame: (0), Week 5, Week 9 (termination) and 2 months later ]
    We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up) vitamin D status: Blood test
  • Health related quality of life [ Time Frame: (0), Week 5, Week 9 (termination) and 2 months later (follow up) ]
    We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up). We will use Health related quality of life questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Vitamin D on Disease Activity in Crohn's Disease
Official Title  ICMJE Not Provided
Brief Summary The purpose for this study is to determine the effect of vitamin D supplementation on disease activity in Crohn's disease patients in Canada and Saudi Arabia
Detailed Description

Hypothesis 1: Patients who are suffering from Crohn's disease are at risk of vitamin D deficiency.

To determine vitamin D status and disease activity in Crohn's disease cases in Canada and Saudi Arabia.

Hypothesis 2: Providing vitamin D in doses higher than RDA (Recommended Dietary Allowance) reduces disease activity in Crohn's disease cases.

To evaluate the impact vitamin D in doses higher than RDA (Recommended Dietary Allowance) on disease activity in Crohn's disease patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE Dietary Supplement: Vitamin D3
Study Arms  ICMJE
  • Experimental: Group 3
    Vitamin D3, 10,000 IU daily
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: Group 2
    Vitamin D3 2,000 IU daily
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: Group 1
    Vitamin D3 600 IU daily (Control group, RDA level)
    Intervention: Dietary Supplement: Vitamin D3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 7, 2018)
9
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2013)
60
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01864616
Other Study ID Numbers  ICMJE VCD-060
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hassanali Vatanparast, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE
  • Dania Alrefai
  • Dr.Jennifer Jones
  • Dr.Hani Jawa
  • Dr.Wael El-matary
  • Saudi Arabian Cultural Bureau
Investigators  ICMJE
Principal Investigator: Hassanali Vatanparast, MD,PhD University of Saskatchewan, Saskatoon, SK,Canada
Study Director: Jennifer Jones, MD,MSc,FRCPC Royal University Hospital, Saskatoon, Saskatchewan, Canada
Study Director: Hani Jawa, MBBS,ABIM,FRCPC King Abdulaziz University, jeddah, Saudi Arabia
Study Director: Wael El-matary, MBChB,MSc,MD,FRCPCH University of Manitoba
Principal Investigator: Dania Alrefai, M.Sc University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP