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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01864616

Enrollment

Registered

2013-05-29

Start date

2013-07-31

Completion date

2015-03-31

Last updated

2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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
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.

Countries

Canada, Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026