An interventional study of ergocalciferol and Cholecalciferol in Inflammatory Bowel Disease, Crohn's Disease and Ulcerative Colitis, sponsored by Boston Children's Hospital. Terminated at 1 site in United States. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2017-03-22.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
2,000 IU/day of ergocalciferol orally for 6 weeks (control arm)
Dietary Supplement: ergocalciferol
2,000 IU/day of cholecalciferol orally for 6 weeks
Dietary Supplement: Cholecalciferol
50,000 IU of ergocalciferol once a week orally for 6 weeks
Dietary Supplement: ergocalciferol
400 IU/day of ergocalciferol orally over 2 years (control arm)
Dietary Supplement: ergocalciferol
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
Dietary Supplement: ergocalciferol
8000 units/ml
Also known as: Vitamin D2
400 units per drop
Also known as: Vitamin D3
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.
Time frame: 6 weeks
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.
Time frame: 12 months
| Milestone | Treatment A | Treatment B | Treatment C | Maintenance A | Maintenance B |
|---|---|---|---|---|---|
| Started | 24 | 24 | 23 | 32 | 31 |
| Completed | 20 | 21 | 20 | 26 | 22 |
| Not completed | 4 | 3 | 3 | 6 | 9 |
| Withdrew: Lost to follow-up | 4 | 0 | 2 | 4 | 7 |
| Withdrew: Adverse event | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 2 | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 1 |
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.
| ng/ml | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease | 9.3 ± 1.8 | 16.4 ± 2.0 | 25.4 ± 2.5 |
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.
| Participants | Maintenance A | Maintenance B |
|---|---|---|
| Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease | 3 | 3 |
Collected over 6 weeks while participant was on study medication for treatment trial. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A | — | 0/24 (0%) | 5/24 (20.8%) |
| Treatment B | — | 0/24 (0%) | 8/24 (33.3%) |
| Treatment C | — | 0/23 (0%) | 4/23 (17.4%) |
| Maintenance A | — | 0/32 (0%) | 19/32 (59.4%) |
| Maintenance B | — | 0/31 (0%) | 15/31 (48.4%) |
| Event | Treatment A | Treatment B | Treatment C | Maintenance A | Maintenance B |
|---|---|---|---|---|---|
| DrowsinessNervous system disorders | 0/24 | 0/24 | 1/23 | 4/32 | 5/31 |
| Increased thirstNervous system disorders | 1/24 | 2/24 | 1/23 | 4/32 | 5/31 |
| Dry mouthGastrointestinal disorders | 0/24 | 1/24 | 0/23 | 5/32 | 3/31 |
| headacheNervous system disorders | 0/24 | 1/24 | 0/23 | 5/32 | 2/31 |
| NauseaGastrointestinal disorders | 3/24 | 1/24 | 2/23 | 5/32 | 4/31 |
| ConstipationGastrointestinal disorders | 0/24 | 1/24 | 1/23 | 2/32 | 4/31 |
| Loss of appetiteGastrointestinal disorders | 1/24 | 2/24 | 0/23 | 4/32 | 2/31 |
| Unusual tiredness, or weaknessGeneral disorders | 0/24 | 0/24 | 0/23 | 4/32 | 3/31 |
| Bone painMusculoskeletal and connective tissue disorders | 1/24 | 0/24 | 1/23 | 3/32 | 2/31 |
| Muscle painMusculoskeletal and connective tissue disorders | 0/24 | 0/24 | 1/23 | 3/32 | 0/31 |
| Age, Continuous(years) | Treatment A | Treatment B | Treatment C | Maintenance A | Maintenance B | Total |
|---|---|---|---|---|---|---|
| Mean | 15.9 ± 3 | 14.7 ± 3.5 | 16.3 ± 3.2 | 15.1 ± 3.1 | 14.5 ± 3.1 | 15.2 ± 3.2 |
| Sex: Female, Male(Participants) | Treatment A | Treatment B | Treatment C | Maintenance A | Maintenance B | Total |
|---|---|---|---|---|---|---|
| Female | 10 | 14 | 9 | 19 | 17 | 69 |
| Male | 14 | 10 | 14 | 13 | 14 | 65 |
Plan to share: No
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