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

Crohn Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01864616
• Other study ID #: VCD-060
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Dietary Supplement:
• Vitamin D3

Locations

Country	Name	City	State
Canada	IBD clinic; Royal University Hospital	Saskatoon	Saskatchewan
Saudi Arabia	Internal Medicine Department; King Abdulaziz University Hospital	Jeddah

Sponsors (6)

Lead Sponsor	Collaborator
University of Saskatchewan	Dania Alrefai, Dr.Hani Jawa, Dr.Jennifer Jones, Dr.Wael El-matary, Saudi Arabian Cultural Bureau

Countries where clinical trial is conducted

Canada,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)

External Links

•   investigator: Hassanali Vatanparast