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

Primary Purpose

Crohn Disease

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Vitamin D3

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Vitamin D, Crohn disease, Disease activity, Inflammation, prevention

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

IBD clinic; Royal University Hospital
Internal Medicine Department; King Abdulaziz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 3

Group 2

Group 1

Arm Description

Vitamin D3, 10,000 IU daily

Vitamin D3 2,000 IU daily

Vitamin D3 600 IU daily (Control group, RDA level)

Outcomes

Primary Outcome Measures

The changes in disease activity on groups

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

nutritional status

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

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

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.

Full Information

NCT ID

NCT01864616

First Posted

May 22, 2013

Last Updated

May 7, 2018

Sponsor

University of Saskatchewan

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01864616

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

We couldn't recruit the sample the we required

Study Start Date

July 2013 (Actual)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Saskatchewan

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

Vitamin D, Crohn disease, Disease activity, Inflammation, prevention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Vitamin D3, 10,000 IU daily

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Vitamin D3 2,000 IU daily

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Vitamin D3 600 IU daily (Control group, RDA level)

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Primary Outcome Measure Information:

Title

The changes in disease activity on groups

Description

Time Frame

(0), 5 weeks, 9 weeks, after 2 months

Secondary Outcome Measure Information:

Title

nutritional status

Description

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.

Time Frame

0, 5 weeks, 9 weeks, 2 months later

Title

vitamin D status

Description

We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up) vitamin D status: Blood test

Time Frame

(0), Week 5, Week 9 (termination) and 2 months later

Title

Health related quality of life

Description

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.

Time Frame

(0), Week 5, Week 9 (termination) and 2 months later (follow up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: