Inflammatory Bowel DiseaseNCT01121796
Influence of Vitamin D on Inflammatory Bowel Disease Remission
A study testing Vitamin D, Water or milk and Vitamin D enriched milk in people with Inflammatory Bowel Disease, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Vitamin D has been shown to influence a multitude of systems. We intend to see whether different types of Vitamin D supplements have an effect on inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Vitamin D, Water or milk and Vitamin D enriched milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Jun 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate inflammatory bowel disease
Who cannot join
- Hypersensitivity to milk products
Trial locations and contacts
1 site in 1 country.
Zvi Fireman, MD contact
Oren Atia, MD contact
About this study
Vitamin D has been shown to influence a multitude of systems. We intend to see whether different types of Vitamin D supplements have an effect on inflammatory bowel disease.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Vitamin D, Water or milk, Vitamin D enriched milk
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Water or milkOther
Vitamin D enriched milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Not described Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Not described Receives: Other: Water or milk |
| Unique vehicle for Vitamin D supplementation | Active comparator | Not described Receives: Dietary Supplement: Vitamin D enriched milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory disease remission
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- Technion, Israel Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121796
- Sponsor's protocol ID
- HY100510
- Status last verified
- May 2010
- First submitted
- 10 May 2010
- Last updated
- 12 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vitamin D on Inflammatory Bowel Disease Remission
- ClinicalTrials.gov ID
- NCT01121796
- Acronym / sponsor ID
- HY100510
- Conditions
- Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (estimated)
- First posted
- 12 May 2010 (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.
Vitamin D has been shown to influence a multitude of systems. We intend to see whether different types of Vitamin D supplements have an effect on inflammatory bowel disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Other: Water or milk |
| Unique vehicle for Vitamin D supplementation | Active comparator | Dietary Supplement: Vitamin D enriched milk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate inflammatory bowel disease
Key exclusion criteria (1 listed)
- Hypersensitivity to milk products
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 D | Dietary supplement | Vitamin D |
| Water or milk | Other | Placebo |
| Vitamin D enriched milk | Dietary supplement | Unique vehicle for Vitamin D supplementation |
Primary outcome
Inflammatory disease remission
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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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.
Zvi Fireman, MD contact
Oren Atia, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D, Water or milk and Vitamin D enriched milk in people with Inflammatory Bowel Disease, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Fireman, MD (fireman@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory disease remission (time frame: One year). 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 12 May 2010.