Inflammatory Bowel DiseaseNCT00621257
Vitamin D Levels in Children With IBD
A study testing ergocalciferol and Cholecalciferol in people with Inflammatory Bowel Disease and Crohn's Disease, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Research has shown that children with Inflammatory Bowel Disease may have lower levels of vitamin D than healthy children, especially in the winter. Vitamin D is important for growing and maintaining healthy bones throughout life, and this is particularly important, since children with IBD frequently have low bone… Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- ergocalciferol and Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of inflammatory bowel disease
- serum 25OHD level ≤ 20 ng/mL (Treatment Trial)
- serum 25OHD level > 20 ng/mL (Maintenance Trial)
Who cannot join
- Patients unable to take medications by mouth, pregnant, with liver/kidney failure, receiving anticonvulsant medications (specifically, phenobarbital, carbamazepine and phenytoin, since they lead to increased vitamin D metabolism through hepatic induction of the cytochrome P450 (CYP450) hydroxylase enzymes), regularly attending a tanning salon (once weekly or more), currently being treated for hypovitaminosis D with therapeutic doses of vitamin D (> 800 IU per day) and unwilling to discontinue this regimen.
- patients on growth hormone, anabolic steroid hormones, calcitonin, bisphosphonates (Maintenance Trial only)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital, Boston
Boston, Massachusetts, 02115
About this study
Official title: Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD.
Research has shown that children with Inflammatory Bowel Disease may have lower levels of vitamin D than healthy children, especially in the winter. Vitamin D is important for growing and maintaining healthy bones throughout life, and this is particularly important, since children with IBD frequently have low bone density. It may also be helpful in the treatment of IBD itself, because it helps reduce inflammation. Vitamin D levels are measured by the amount of 25 OHD in the blood; however, measuring this level on a regular basis is not yet the standard for children with IBD. The purpose of this study is to find the best way to treat low vitamin D levels, and to maintain good vitamin D levels throughout the year. It will also test whether having higher vitamin D levels will improve the bone health of children with IBD, and whether it will help them have milder disease.
Read the detailed description
Vitamin D is essential for bone mineralization. The prevalence of vitamin D insufficiency [serum 25-hydroxy-vitamin D concentration (25OHD) ≤ 20 ng/mL] is high among adults with inflammatory bowel disease (IBD), and even higher in pediatric patients with IBD. Protein-losing enteropathy could represent both an etiologic factor for hypovitaminosis D, and an obstacle in treating it in IBD patients. There are currently no guidelines for the treatment of hypovitaminosis D in adults or children with IBD. Moreover we have obtained evidence that optimal vitamin D stores (25OHD ≥32 ng/mL) may not be maintained throughout the year in patients with IBD following current RDA recommendations. On the other hand, the prevalence of low bone mineral density is high among young patients with IBD, during a period in their lives when they should experience the most rapid acquisition of bone mass. Optimization of vitamin D status and its impact on the bone health of children with IBD has not been studied. In addition, vitamin D may play an important role in the regulation of the immune system as supported by animal models of colitis and in vitro human studies.
Prospective studies of the effect of vitamin D supplementation on disease outcomes have not been undertaken in children with IBD to date. We aim to perform a) a randomized controlled trial to compare the efficacy of 3 regimens in treating vitamin D insufficiency in pediatric patients with IBD over a period of 6 weeks. We will also evaluate the effects of each regimen on markers of bone resorption, bone formation and parathyroid hormone levels, and the relationship between the magnitude of gastrointestinal protein loss, as reflected by clearance of fecal alpha -1-antitrypsin, and the efficacy of the treatment. b) We also aim to perform a randomized controlled trial to compare the efficacy of 2 regimens of different doses of oral vitamin D2 in maintaining optimal vitamin D stores in pediatric patients with IBD over a period of 2 years. We intend to study the effect of each regimen on a) bone mass acquisition (measured via DXA and pQCT) and bone strength (measured via pQCT), b) bone formation and resorption markers and parathyroid hormone, and c) disease outcomes and disease severity over the same period of time.
- Being tested
- ergocalciferol, Cholecalciferol
- Keywords
- IBD, Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Vitamin D
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergocalciferolDietary supplement
Also called Vitamin D2
8000 units/ml
CholecalciferolDietary supplement
Also called Vitamin D3
400 units per drop
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | 2,000 IU/day of ergocalciferol orally for 6 weeks (control arm) Receives: Dietary Supplement: ergocalciferol |
| Treatment B | Experimental | 2,000 IU/day of cholecalciferol orally for 6 weeks Receives: Dietary Supplement: Cholecalciferol |
| Treatment C | Experimental | 50,000 IU of ergocalciferol once a week orally for 6 weeks Receives: Dietary Supplement: ergocalciferol |
| Maintenance A | Active comparator | 400 IU/day of ergocalciferol orally over 2 years (control arm) Receives: Dietary Supplement: ergocalciferol |
| Maintenance B | Experimental | 2,000 IU/day of ergocalciferol orally from November 1 to April 30, and 1,000 IU/day of ergocalciferol orally for the remainder of the year over 2 years Receives: Dietary Supplement: ergocalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease.
25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores.
Measured: 6 weeks
Secondary outcomes (1)
Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
Percentage of pediatric patients with inflammatory bowel disease who maintained their serum 25OHD level at or above 32 ng/mL at all study visits over the duration of the maintenance study 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores. Concentration at or above 32 ng/mL has been identified as optimal vitamin D level for bone health by majority of experts.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Maintenance phase outcome unattenable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Crohn's and Colitis Foundation, NASPGHAN Foundation
- Responsible party
- Principal investigator, Helen Pappa, Boston Children's Hospital
- Investigators
- Helen Pappa, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621257
- Sponsor's protocol ID
- 1K23DK076979-01A1
- Other IDs
- 1K23DK076979-01A1
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2008
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pappa HM, Mitchell PD, Jiang H, Kassiff S, Filip-Dhima R, DiFabio D, Quinn N, Lawton RC, Bronzwaer ME, Koenen M, Gordon CM. Maintenance of optimal vitamin D status in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing two regimens. J Clin Endocrinol Metab. 2014 Sep;99(9):3408-17. doi: 10.1210/jc.2013-4218. Epub 2014 Jun 13.
PubMed 24926949Pappa HM, Mitchell PD, Jiang H, Kassiff S, Filip-Dhima R, DiFabio D, Quinn N, Lawton RC, Varvaris M, Van Straaten S, Gordon CM. Treatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens. J Clin Endocrinol Metab. 2012 Jun;97(6):2134-42. doi: 10.1210/jc.2011-3182. Epub 2012 Mar 28.
PubMed 22456619
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD.
- ClinicalTrials.gov ID
- NCT00621257
- Acronym / sponsor ID
- 1K23DK076979-01A1
- Keywords
- IBD, Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Vitamin D
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Maintenance phase outcome unattenable
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Crohn's and Colitis Foundation, NASPGHAN Foundation
- Study start
- Jan 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research has shown that children with Inflammatory Bowel Disease may have lower levels of vitamin D than healthy children, especially in the winter. Vitamin D is important for growing and maintaining healthy bones throughout life, and this is particularly important, since children with IBD frequently have low bone density. It may also be helpful in the treatment of IBD itself, because it helps reduce inflammation. Vitamin D levels are measured by the amount of 25 OHD in the blood; however, measuring this level on a regular basis is not yet the standard for children with IBD. The purpose of this study is to find the best way to treat low vitamin D levels, and to maintain good vitamin D levels throughout the year. It will also test whether having higher vitamin D levels will improve the bone health of children with IBD, and whether it will help them have milder disease.
Detailed description
Vitamin D is essential for bone mineralization. The prevalence of vitamin D insufficiency [serum 25-hydroxy-vitamin D concentration (25OHD) ≤ 20 ng/mL] is high among adults with inflammatory bowel disease (IBD), and even higher in pediatric patients with IBD. Protein-losing enteropathy could represent both an etiologic factor for hypovitaminosis D, and an obstacle in treating it in IBD patients. There are currently no guidelines for the treatment of hypovitaminosis D in adults or children with IBD. Moreover we have obtained evidence that optimal vitamin D stores (25OHD ≥32 ng/mL) may not be maintained throughout the year in patients with IBD following current RDA recommendations. On the other hand, the prevalence of low bone mineral density is high among young patients with IBD, during a period in their lives when they should experience the most rapid acquisition of bone mass. Optimization of vitamin D status and its impact on the bone health of children with IBD has not been studied. In addition, vitamin D may play an important role in the regulation of the immune system as supported by animal models of colitis and in vitro human studies.
Prospective studies of the effect of vitamin D supplementation on disease outcomes have not been undertaken in children with IBD to date. We aim to perform a) a randomized controlled trial to compare the efficacy of 3 regimens in treating vitamin D insufficiency in pediatric patients with IBD over a period of 6 weeks. We will also evaluate the effects of each regimen on markers of bone resorption, bone formation and parathyroid hormone levels, and the relationship between the magnitude of gastrointestinal protein loss, as reflected by clearance of fecal alpha -1-antitrypsin, and the efficacy of the treatment. b) We also aim to perform a randomized controlled trial to compare the efficacy of 2 regimens of different doses of oral vitamin D2 in maintaining optimal vitamin D stores in pediatric patients with IBD over a period of 2 years. We intend to study the effect of each regimen on a) bone mass acquisition (measured via DXA and pQCT) and bone strength (measured via pQCT), b) bone formation and resorption markers and parathyroid hormone, and c) disease outcomes and disease severity over the same period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Dietary Supplement: ergocalciferol2,000 IU/day of ergocalciferol orally for 6 weeks (control arm) |
| Treatment B | Experimental | Dietary Supplement: Cholecalciferol2,000 IU/day of cholecalciferol orally for 6 weeks |
| Treatment C | Experimental | Dietary Supplement: ergocalciferol50,000 IU of ergocalciferol once a week orally for 6 weeks |
| Maintenance A | Active comparator | Dietary Supplement: ergocalciferol400 IU/day of ergocalciferol orally over 2 years (control arm) |
| Maintenance B | Experimental | Dietary Supplement: ergocalciferol2,000 IU/day of ergocalciferol orally from November 1 to April 30, and 1,000 IU/day of ergocalciferol orally for the remainder of the year over 2 years |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of inflammatory bowel disease
- serum 25OHD level ≤ 20 ng/mL (Treatment Trial)
- serum 25OHD level > 20 ng/mL (Maintenance Trial)
Key exclusion criteria (2 listed)
- Patients unable to take medications by mouth, pregnant, with liver/kidney failure, receiving anticonvulsant medications (specifically, phenobarbital, carbamazepine and phenytoin, since they lead to increased vitamin D metabolism through hepatic induction of the cytochrome P450 (CYP450) hydroxylase enzymes), regularly attending a tanning salon (once weekly or more), currently being treated for hypovitaminosis D with therapeutic doses of vitamin D (> 800 IU per day) and unwilling to discontinue this regimen.
- patients on growth hormone, anabolic steroid hormones, calcitonin, bisphosphonates (Maintenance Trial only)
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 |
|---|---|---|
| ergocalciferolAlso: Vitamin D28000 units/ml | Dietary supplement | Maintenance A, Maintenance B, Treatment A, Treatment C |
| CholecalciferolAlso: Vitamin D3400 units per drop | Dietary supplement | Treatment B |
Primary outcome
Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
Time frame: 6 weeks
Change in serum 25OHD levels after treatment with vitamin D formulations for 6 weeks in pediatric patients with inflammatory bowel disease. 25OHD is the most abundant vitamin D metabolite, which is bound to vitamin D binding protein. The measurement of its concentration in serum, reflects vitamin D stores.
1 secondary outcome
Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24926949Pappa HM, Mitchell PD, Jiang H, Kassiff S, Filip-Dhima R, DiFabio D, Quinn N, Lawton RC, Bronzwaer ME, Koenen M, Gordon CM. Maintenance of optimal vitamin D status in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing two regimens. J Clin Endocrinol Metab. 2014 Sep;99(9):3408-17. doi: 10.1210/jc.2013-4218. Epub 2014 Jun 13.
- Derived from this study: PubMed 22456619Pappa HM, Mitchell PD, Jiang H, Kassiff S, Filip-Dhima R, DiFabio D, Quinn N, Lawton RC, Varvaris M, Van Straaten S, Gordon CM. Treatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens. J Clin Endocrinol Metab. 2012 Jun;97(6):2134-42. doi: 10.1210/jc.2011-3182. Epub 2012 Mar 28.
- Boston Children's Hospital Center for Inflammatory Bowel DiseasesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Helen Pappa, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ergocalciferol and Cholecalciferol in people with Inflammatory Bowel Disease and Crohn's Disease, run by Boston Children's Hospital 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 3 inclusion and 2 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 22 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease (time frame: 6 weeks). 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 NCT00621257, which also lists 2 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 22 Mar 2017.