Vitamin D Levels in Children With IBD
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 5 - 21 |
| Updated: | 4/2/2016 |
| Start Date: | January 2008 |
| End Date: | January 2012 |
| Contact: | Helen Pappa, MD, MPH |
| Email: | helen.pappa@childrens.harvard.edu |
| Phone: | 617-355-2962 |
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.
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.
[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.
Inclusion Criteria:
- Clinical diagnosis of inflammatory bowel disease
- serum 25OHD level ≤ 20 ng/mL (Treatment Trial)
- serum 25OHD level > 20 ng/mL (Maintenance Trial)
Exclusion Criteria:
- 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)
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