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Vitamin D3 for Inflammatory Bowel Disease (IBD)
Phase 3
Waitlist Available
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be monitored for urinary symptoms and complete serial urine assessments as outlined in the protocol. the impact of oral vitamin d administration on calcium excretion will be evaluated during and at the conclusion of this one-year study.
Awards & highlights
Study Summary
This trial will test if high doses of Vitamin D3 are safe and effective in treating children and young adults with Inflammatory Bowel Disease.
Eligible Conditions
- Inflammatory Bowel Disease
- Crohn's Disease
- Ulcerative Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will continue to receive oral vitamin d therapy for one year. we will be assessing the efficacy of oral vitamin d therapy, in this dosing schema, to result in 25-oh vitamin d levels during and at the conclusion of this one-year study.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will continue to receive oral vitamin d therapy for one year. we will be assessing the efficacy of oral vitamin d therapy, in this dosing schema, to result in 25-oh vitamin d levels during and at the conclusion of this one-year study.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range
Secondary outcome measures
Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D
Trial Design
1Treatment groups
Experimental Treatment
Group I: Vitamin D3 TreatmentExperimental Treatment1 Intervention
Subjects receiving Remicade will be treated with oral Vitamin D3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholecalciferol
FDA approved
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
760 Previous Clinical Trials
5,579,630 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had kidney problems in the past.You are currently taking medication for seizures.You are pregnant.You cannot take Vitamin D orally.You have been diagnosed with inflammatory bowel disease (IBD).
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin D3 Treatment
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some common illnesses that Vitamin D3 can help alleviate?
"Vitamin D3 is an effective method of treatment for calcium, fracture, and spine fracture."
Answered by AI
Are people aged 40 or older eligible to participate in this research project?
"Children that meet the age requirements for this study (between 7 and 25 years old) are eligible to participate."
Answered by AI
Could you please summarize the prior research on Vitamin D3's efficacy?
"At the moment, 37 different ongoing trials are studying the effects of Vitamin D3 with 15 of those in Phase 3. Most of the research being conducted on Vitamin D3 is happening in Boston, Massachusetts; however, there are a total of 171 research sites around the world."
Answered by AI
What are the risks associated with Vitamin D3 supplementation?
"There is both prior clinical data supporting Vitamin D3's safety as well as multiple rounds of data, so it received a score of 3."
Answered by AI
Are we still recruiting patients for this clinical trial?
"According to the clinicaltrials.gov website, this trial is still recruiting patients. The listing was created on 8/1/2017 and was last updated on 8/4/2022. They are looking for 50 individuals to participate at 1 site."
Answered by AI
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