Crohn's Disease (CD)NCT01877577
Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D
A study testing Vitamin D3 in people with Crohn's Disease (CD) and Ulcerative Colitis (UC), run by University of California, San Francisco at 1 site in United States.
Trial summary
This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Sep 2013
- 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
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- 18 years of age or older
- 25(OH)D levels <30ng/ml
- willing to give informed written consent
Who cannot join
- Age < 18 years
- Women who are pregnant or planning to become pregnant
- Patients already taking vitamin D3 ≥2,000 IU/daily prior to study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Regional Medical Center, Ambulatory Care Center
Fresno, California, 93721
About this study
Official title: Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.
This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them.
Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.
Read the detailed description
The incidence of hypovitaminosis D has been reported to be as high as 75% in patients with IBD. However, it is unclear whether low vitamin D levels contribute to the pathogenesis of IBD or are a consequence of IBD. Recent animal data studies suggest that maintenance of the epithelial barrier integrity in the large intestine by vitamin D is important in preventing IBD.
However, more evidence is required to determine the effect of vitamin D3 supplementation in patients with IBD. Furthermore, there is no clear consensus regarding the appropriate dose of vitamin D supplementation in IBD patients.
- Conditions
- Crohn's Disease (CD), Ulcerative Colitis (UC)
- Being tested
- Vitamin D3
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called vitamin D3 cholecalciferol
Study patients who took 2,000 IU daily of vitamin D3 will be compared to those who took 4,000 IU daily to determine the different effects of vitamin D3 dose on quality of life, disease activity, and the laboratory tests in this study.
| Study group | Role | What they receive |
|---|---|---|
| 2000 I/U Vitamin D3 | Active comparator | 2000 I/U Vitamin D3 Daily Receives: Dietary Supplement: Vitamin D3 |
| 4000 I/U Vitamin D3 | Active comparator | 4000 I/U Vitamin D3 Daily Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D3 supplementation in IBD patients with hypovitaminosis D.
To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D.
Measured: 90 days after patient taking the Vitamin D3 supplement daily
Secondary outcomes (1)
vitamin D3 supplementation on disease activity and quality of life
To assess the effect of vitamin D3 supplementation on IBD disease activity and quality of life in patients with IBD and hypovitaminosis D.
Measured: 90 days after patient taking the Vitamin D3 supplement daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn's Disease (CD)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Limsui, MD, Principal investigator, Assistant Clinical Professor, UCSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877577
- Sponsor's protocol ID
- IBDVitD-42012
- Status last verified
- Jul 2014
- First submitted
- 11 Jun 2013
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209.
PubMed 21677747Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267.
PubMed 21527593Kong J, Zhang Z, Musch MW, Ning G, Sun J, Hart J, Bissonnette M, Li YC. Novel role of the vitamin D receptor in maintaining the integrity of the intestinal mucosal barrier. Am J Physiol Gastrointest Liver Physiol. 2008 Jan;294(1):G208-16. doi: 10.1152/ajpgi.00398.2007. Epub 2007 Oct 25.
PubMed 17962355Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.
PubMed 21118827
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01877577
- Acronym / sponsor ID
- IBDVitD-42012
- Conditions
- Crohn's Disease (CD), Ulcerative Colitis (UC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Jun 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.
This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them.
Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.
Detailed description
The incidence of hypovitaminosis D has been reported to be as high as 75% in patients with IBD. However, it is unclear whether low vitamin D levels contribute to the pathogenesis of IBD or are a consequence of IBD. Recent animal data studies suggest that maintenance of the epithelial barrier integrity in the large intestine by vitamin D is important in preventing IBD.
However, more evidence is required to determine the effect of vitamin D3 supplementation in patients with IBD. Furthermore, there is no clear consensus regarding the appropriate dose of vitamin D supplementation in IBD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2000 I/U Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D32000 I/U Vitamin D3 Daily |
| 4000 I/U Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D34000 I/U Vitamin D3 Daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- 18 years of age or older
- 25(OH)D levels <30ng/ml
- willing to give informed written consent
Key exclusion criteria (3 listed)
- Age < 18 years
- Women who are pregnant or planning to become pregnant
- Patients already taking vitamin D3 ≥2,000 IU/daily prior to study enrollment
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 D3Also: vitamin D3 cholecalciferolStudy patients who took 2,000 IU daily of vitamin D3 will be compared to those who took 4,000 IU daily to determine the different effects of vitamin D3 dose on quality of life, disease activity, and the laboratory tests in this study. | Dietary supplement | 2000 I/U Vitamin D3, 4000 I/U Vitamin D3 |
Primary outcome
vitamin D3 supplementation in IBD patients with hypovitaminosis D.
Time frame: 90 days after patient taking the Vitamin D3 supplement daily
To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D.
1 secondary outcome
vitamin D3 supplementation on disease activity and quality of life
Time frame: 90 days after patient taking the Vitamin D3 supplement daily
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
- Background: PubMed 21677747Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209.
- Background: PubMed 21527593Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267.
- Background: PubMed 17962355Kong J, Zhang Z, Musch MW, Ning G, Sun J, Hart J, Bissonnette M, Li YC. Novel role of the vitamin D receptor in maintaining the integrity of the intestinal mucosal barrier. Am J Physiol Gastrointest Liver Physiol. 2008 Jan;294(1):G208-16. doi: 10.1152/ajpgi.00398.2007. Epub 2007 Oct 25.
- Background: PubMed 21118827Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.
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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.
David Limsui, MD principal investigator
Assistant Clinical Professor, UCSF
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 D3 in people with Crohn's Disease (CD) and Ulcerative Colitis (UC), run by University of California, San Francisco at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Jul 2014. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
vitamin D3 supplementation in IBD patients with hypovitaminosis D. (time frame: 90 days after patient taking the Vitamin D3 supplement daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877577, which also lists 4 linked publications.
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 2 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.