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

Study Overview
=================
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.

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 3<br>Vitamin D3, 10,000 IU daily | Dietary Supplement: Vitamin D3<br> <br> |
| Experimental: Group 2<br>Vitamin D3 2,000 IU daily | Dietary Supplement: Vitamin D3<br> <br> |
| Experimental: Group 1<br>Vitamin D3 600 IU daily (Control group, RDA level) | Dietary Supplement: Vitamin D3<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Crohn disease, Disease activity, Inflammation, prevention