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

University of Saskatchewan

Status: Terminated

Conditions: Crohn Disease

Treatments: Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01864616

VCD-060

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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9 participants in 3 patient groups

Group 3

Experimental group

Description:

Vitamin D3, 10,000 IU daily

Treatment:

Dietary Supplement: Vitamin D3

Group 2

Experimental group

Description:

Vitamin D3 2,000 IU daily

Treatment:

Dietary Supplement: Vitamin D3

Group 1

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D3