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

May 7, 2018 updated by: Hassanali Vatanparast, University of Saskatchewan
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • IBD clinic; Royal University Hospital
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • Internal Medicine Department; King Abdulaziz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
(0), 5 weeks, 9 weeks, after 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 5 weeks, 9 weeks, 2 months later
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
(0), Week 5, Week 9 (termination) and 2 months later
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.
(0), Week 5, Week 9 (termination) and 2 months later (follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Dania Alrefai
Dr.Jennifer Jones
Dr.Hani Jawa
Dr.Wael El-matary
Saudi Arabian Cultural Bureau

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCD-060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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