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

Not Applicable

Terminated

• Conditions: Crohn Disease
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT01864616
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Study Start: 2013-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Vitamin D3	Vitamin D3 2,000 IU daily
Group 1	Vitamin D3	Vitamin D3 600 IU daily (Control group, RDA level)
Group 3	Vitamin D3	Vitamin D3, 10,000 IU daily

Primary Outcome Measures

Name	Time	Method
The changes in disease activity on groups	(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

Name	Time	Method
nutritional status	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.
Health related quality of life	(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.
vitamin D status	(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

Trial Locations

Locations (2)

IBD clinic; Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Internal Medicine Department; King Abdulaziz University Hospital; 🇸🇦 Jeddah, Saudi Arabia