Crohn DiseaseNCT01864616
The Impact of Vitamin D on Disease Activity in Crohn's Disease
A study testing Vitamin D3 in people with Crohn Disease, run by University of Saskatchewan at 2 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- newly diagnosis with an active Crohn's disease,
- age above of 16 years
Who cannot join
- remission or the duration of disease is more than 2 years,
- pregnancy,
- liver or kidney failure,
- inability to take oral supplements or medicine
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Saudi Arabia1 site
Internal Medicine Department; King Abdulaziz University Hospital
Jeddah
About this study
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
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Vitamin D3
- Keywords
- Vitamin D, Crohn disease, Disease activity, Inflammation, prevention
- Medical subject headings
- Crohn Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Group 3 | Experimental | Vitamin D3, 10,000 IU daily Receives: Dietary Supplement: Vitamin D3 |
| Group 2 | Experimental | Vitamin D3 2,000 IU daily Receives: Dietary Supplement: Vitamin D3 |
| Group 1 | Experimental | Vitamin D3 600 IU daily (Control group, RDA level) Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: (0), 5 weeks, 9 weeks, after 2 months
Secondary outcomes (3)
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.
Measured: 0, 5 weeks, 9 weeks, 2 months later
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
Measured: (0), Week 5, Week 9 (termination) and 2 months later
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.
Measured: (0), Week 5, Week 9 (termination) and 2 months later (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: We couldn't recruit the sample the we required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Dania Alrefai, Dr.Jennifer Jones, Dr.Hani Jawa, Dr.Wael El-matary, Saudi Arabian Cultural Bureau
- Responsible party
- Principal investigator, Hassanali Vatanparast, University of Saskatchewan
- Investigators
- Hassanali Vatanparast, MD,PhD, Principal investigator, University of Saskatchewan, Saskatoon, SK,CanadaJennifer Jones, MD,MSc,FRCPC, Study director, Royal University Hospital, Saskatoon, Saskatchewan, CanadaHani Jawa, MBBS,ABIM,FRCPC, Study director, King Abdulaziz University, jeddah, Saudi ArabiaWael El-matary, MBChB,MSc,MD,FRCPCH, Study director, University of ManitobaDania Alrefai, M.Sc, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864616
- Sponsor's protocol ID
- VCD-060
- Status last verified
- May 2018
- First submitted
- 22 May 2013
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin D on Disease Activity in Crohn's Disease
- ClinicalTrials.gov ID
- NCT01864616
- Acronym / sponsor ID
- VCD-060
- Conditions
- Crohn Disease
- Keywords
- Vitamin D, Crohn disease, Disease activity, Inflammation, prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We couldn't recruit the sample the we required
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Dania Alrefai, Dr.Jennifer Jones, Dr.Hani Jawa, Dr.Wael El-matary, Saudi Arabian Cultural Bureau
- Study start
- Jul 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 3 | Experimental | Dietary Supplement: Vitamin D3Vitamin D3, 10,000 IU daily |
| Group 2 | Experimental | Dietary Supplement: Vitamin D3Vitamin D3 2,000 IU daily |
| Group 1 | Experimental | Dietary Supplement: Vitamin D3Vitamin D3 600 IU daily (Control group, RDA level) |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- newly diagnosis with an active Crohn's disease,
- age above of 16 years
Key exclusion criteria (4 listed)
- remission or the duration of disease is more than 2 years,
- pregnancy,
- liver or kidney failure,
- inability to take oral supplements or medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 | Dietary supplement | Group 1, Group 2, Group 3 |
Primary outcome
The changes in disease activity on groups
Time frame: (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".
3 secondary outcomes
nutritional status
Time frame: 0, 5 weeks, 9 weeks, 2 months later
vitamin D status
Time frame: (0), Week 5, Week 9 (termination) and 2 months later
Health related quality of life
Time frame: (0), Week 5, Week 9 (termination) and 2 months later (follow up)
Results and safety
The study was stopped early (reason given: We couldn't recruit the sample the we required). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassanali Vatanparast, MD,PhD principal investigator
University of Saskatchewan, Saskatoon, SK,Canada
Jennifer Jones, MD,MSc,FRCPC study director
Royal University Hospital, Saskatoon, Saskatchewan, Canada
Hani Jawa, MBBS,ABIM,FRCPC study director
King Abdulaziz University, jeddah, Saudi Arabia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Crohn Disease, run by University of Saskatchewan at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We couldn't recruit the sample the we required). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in disease activity on groups (time frame: (0), 5 weeks, 9 weeks, after 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.