Crohns DiseaseEarly Phase 1NCT03615378
Maintenance Dosing of Vitamin D in Crohn's Disease
A Early Phase 1 study testing 5000 IU D3 and 1000 IU D3 in people with Crohns Disease and Vitamin D Deficiency, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Vitamin D repletion is important for bone health in patients with Crohn's disease. While repletion strategies in the general population yield similar results in those with Crohn's disease, maintenance strategies are variable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohns Disease, Vitamin D Deficiency
- What is being tested?
- 5000 IU D3 and 1000 IU D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 30 Nov 2018
- Phase
- Early Phase 1
- 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
- Diagnosis of Crohn's disease
- In clinical remission as determined by the Harvey Bradshaw Index (CD) ≤4
- 25(OH)D level <30 ng/ml within three months of study enrollment
- Prior 25(OH)D level <30 ng/ml currently on repletion therapy
- Provided written informed consent
- 18 years of age or older
- All maintenance therapies required to be on stable doses for 3 months.
Who cannot join
- Unwilling to provide consent or lack capacity
- Clinical disease activity (Harvey Bradshaw index >4)
- Current pregnancy or attempting to conceive
- Hypercalcemia (must have calcium level within 6 months of enrollment)
- Known coexisting hyperparathyroidism
- BMI >30 kg/m²
Show all 16Show fewer
- History of kidney stones
- Subjects <18 years of age - pediatric population with different recommended dosing than adults
- Non-english speakers
- Has an ileo-anal pouch or ileostomy
- C-reactive protein greater than 2x the upper limit of normal
- Lactose intolerant
- Short gut syndrome
- Renal insufficiency (CrCl <60 ml/min)
- Concomitant therapy with thiazide diuretics, barbiturates, digitalis or supplemental products containing vitamin D
- Vitamin D levels <30ng/ml at completion of lead in
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission
Vitamin D repletion is important for bone health in patients with Crohn's disease. While repletion strategies in the general population yield similar results in those with Crohn's disease, maintenance strategies are variable. High quality evidence is lacking to determine the optimal strategy to maintain adequate levels of Vitamin D levels in patients with Crohn's disease.
Read the detailed description
The investigators seek to identify patients with Crohn's disease in clinical remission who have vitamin D levels <30 ng/ml. Subjects will undergo a 8 week lead in period and receive Vitamin D supplementation with 50,000 IU D2 weekly for 8 weeks.Participants with sufficient Vitamin D levels after 8 weeks (>30 ng/mL) will be enrolled into the study and randomized to one of three arms: (1) placebo (2) 1000 IU/day Vitamin D3 (3) 5,000 IU/day Vitamin D3 for 22 weeks. Based on clinical experience, doses higher than the recommended doses for bone health in the general population (600-800 IU/day Vitamin D3) are needed to achieve and maintain optimal levels of Vitamin D in people with Crohn's disease.
The investigators aim to determine optimal maintenance dosing to sustain vitamin D sufficiency in people with Crohn's disease. The investigators also seek to determine demographic and disease related characteristics associated with inability to maintain sufficient levels.
- Conditions
- Crohns Disease, Vitamin D Deficiency
- Being tested
- 5000 IU D3, 1000 IU D3, Placebo
- Medical subject headings
- Crohn Disease, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5000 IU D3Dietary supplement
Daily
1000 IU D3Dietary supplement
Daily
PlaceboDietary supplement
lactose/sugar tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Vitamin D 1000 IU D3 daily | Active comparator | Not described Receives: Dietary Supplement: 1000 IU D3 |
| Vitamin D 5000 IU D3 daily | Active comparator | Not described Receives: Dietary Supplement: 5000 IU D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D serum level Vitamin D sufficiency
Serum level greater than or equal to 30 ng/ml
Measured: 22 weeks
Secondary outcomes (1)
Time to Vitamin D Insufficiency
Time (in weeks) from the measurement of sufficiency (at week 0) to Vitamin D insufficiency (defined as serum vitamin D level less than 30 ng/mL)
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start30 Aug 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Why it stopped: Difficulties with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Melmed, Cedars-Sinai Medical Center
- Investigators
- GIl Y Melmed, MD, MS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615378
- Sponsor's protocol ID
- Pro50335
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No information will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission
- ClinicalTrials.gov ID
- NCT03615378
- Acronym / sponsor ID
- Pro50335
- Conditions
- Crohns Disease, Vitamin D Deficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- 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 repletion is important for bone health in patients with Crohn's disease. While repletion strategies in the general population yield similar results in those with Crohn's disease, maintenance strategies are variable. High quality evidence is lacking to determine the optimal strategy to maintain adequate levels of Vitamin D levels in patients with Crohn's disease.
Detailed description
The investigators seek to identify patients with Crohn's disease in clinical remission who have vitamin D levels <30 ng/ml. Subjects will undergo a 8 week lead in period and receive Vitamin D supplementation with 50,000 IU D2 weekly for 8 weeks.Participants with sufficient Vitamin D levels after 8 weeks (>30 ng/mL) will be enrolled into the study and randomized to one of three arms: (1) placebo (2) 1000 IU/day Vitamin D3 (3) 5,000 IU/day Vitamin D3 for 22 weeks. Based on clinical experience, doses higher than the recommended doses for bone health in the general population (600-800 IU/day Vitamin D3) are needed to achieve and maintain optimal levels of Vitamin D in people with Crohn's disease.
The investigators aim to determine optimal maintenance dosing to sustain vitamin D sufficiency in people with Crohn's disease. The investigators also seek to determine demographic and disease related characteristics associated with inability to maintain sufficient levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Vitamin D 1000 IU D3 daily | Active comparator | Dietary Supplement: 1000 IU D3 |
| Vitamin D 5000 IU D3 daily | Active comparator | Dietary Supplement: 5000 IU D3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Crohn's disease
- In clinical remission as determined by the Harvey Bradshaw Index (CD) ≤4
- 25(OH)D level <30 ng/ml within three months of study enrollment
- Prior 25(OH)D level <30 ng/ml currently on repletion therapy
- Provided written informed consent
Key exclusion criteria (16 listed)
- Unwilling to provide consent or lack capacity
- Clinical disease activity (Harvey Bradshaw index >4)
- Current pregnancy or attempting to conceive
- Hypercalcemia (must have calcium level within 6 months of enrollment)
- Known coexisting hyperparathyroidism
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 |
|---|---|---|
| 5000 IU D3Daily | Dietary supplement | Vitamin D 5000 IU D3 daily |
| 1000 IU D3Daily | Dietary supplement | Vitamin D 1000 IU D3 daily |
| Placebolactose/sugar tablet | Dietary supplement | Placebo |
Primary outcome
Vitamin D serum level Vitamin D sufficiency
Time frame: 22 weeks
Serum level greater than or equal to 30 ng/ml
1 secondary outcome
Time to Vitamin D Insufficiency
Time frame: 22 weeks
Results and safety
The study was stopped early (reason given: Difficulties with enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No. No information will be shared
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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.
GIl Y Melmed, MD, MS principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 5000 IU D3 and 1000 IU D3 in people with Crohns Disease and Vitamin D Deficiency, run by Cedars-Sinai Medical Center 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 7 inclusion and 16 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 24 Jul 2019. 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. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties with enrollment). 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?
Vitamin D serum level Vitamin D sufficiency (time frame: 22 weeks). 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 24 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.