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

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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

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

Condition or disease Intervention/treatment Phase
Crohn Disease Dietary Supplement: Vitamin D3 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : July 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Group 3
Vitamin D3, 10,000 IU daily
Dietary Supplement: Vitamin D3
Experimental: Group 2
Vitamin D3 2,000 IU daily
Dietary Supplement: Vitamin D3
Experimental: Group 1
Vitamin D3 600 IU daily (Control group, RDA level)
Dietary Supplement: Vitamin D3



Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864616


Locations
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Canada, Saskatchewan
IBD clinic; Royal University Hospital
Saskatoon, Saskatchewan, Canada
Saudi Arabia
Internal Medicine Department; King Abdulaziz University Hospital
Jeddah, Saudi Arabia
Sponsors and Collaborators
University of Saskatchewan
Dania Alrefai
Dr.Jennifer Jones
Dr.Hani Jawa
Dr.Wael El-matary
Saudi Arabian Cultural Bureau
Investigators
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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

Additional Information:
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Responsible Party: Hassanali Vatanparast, Associate Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01864616     History of Changes
Other Study ID Numbers: VCD-060
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hassanali Vatanparast, University of Saskatchewan:
Vitamin D
Crohn disease
Disease activity
Inflammation
prevention
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents