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

University of Saskatchewan9 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Crohn Disease

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

IBD clinic; Royal University Hospital

Saskatoon, Saskatchewan, Canada

Internal Medicine Department; King Abdulaziz University Hospital

Jeddah, Saudi Arabia

Outcomes

Primary Outcomes

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".

Time frame: (0), 5 weeks, 9 weeks, after 2 months

Secondary Outcomes

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.

Time frame: 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

Time frame: (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.

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

Data from ClinicalTrials.gov

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