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

NCT01864616 | Terminated

• 1 other identifier: VCD-060
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 2

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

Conditions

Crohn Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• nutritional status

  0, 5 weeks, 9 weeks, 2 months later

• vitamin D status

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

• Health related quality of life

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

Study Arms (3)

Group 3

EXPERIMENTAL

Vitamin D3, 10,000 IU daily

Dietary Supplement: Vitamin D3

Group 2

EXPERIMENTAL

Vitamin D3 2,000 IU daily

Dietary Supplement: Vitamin D3

Group 1

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosis with an active Crohn's disease,
• age above of 16 years

You may not qualify if:

• remission or the duration of disease is more than 2 years,
• pregnancy,
• liver or kidney failure,
• inability to take oral supplements or medicine

Sponsors & Collaborators

• University of Saskatchewan: lead
• Dania Alrefai: collaborator
• Dr.Jennifer Jones: collaborator
• Dr.Hani Jawa: collaborator
• Dr.Wael El-matary: collaborator
• Saudi Arabian Cultural Bureau: collaborator

Study Sites (2)

IBD clinic; Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

Internal Medicine Department; King Abdulaziz University Hospital

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Crohn Disease; Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Hassanali Vatanparast, MD,PhD

  University of Saskatchewan, Saskatoon, SK,Canada

  PRINCIPAL INVESTIGATOR

• Jennifer Jones, MD,MSc,FRCPC

  Royal University Hospital, Saskatoon, Saskatchewan, Canada

  STUDY DIRECTOR

• Hani Jawa, MBBS,ABIM,FRCPC

  King Abdulaziz University, jeddah, Saudi Arabia

  STUDY DIRECTOR

• Wael El-matary, MBChB,MSc,MD,FRCPCH

  University of Manitoba

  STUDY DIRECTOR

• Dania Alrefai, M.Sc

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 29, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

SA (1); CA (1)