BACKGROUND: Patients who have been diagnosed with Inflammatory Bowel Disease (IBD) present with increased risk of deficient vitamin D levels. Previous studies have demonstrated that these IBD patients who live in areas with lack of sun exposure are especially susceptible to becoming vitamin D deficient. Studies have also shown that the standard vitamin D dosing protocols have not proven effective in consistently improving vitamin D status. This failure is likely related to a combination of under-dosing and patient noncompliance. Vitamin D sufficiency is essential in the maintenance of both skeletal health and the immune system in children and adolescents.
OBJECTIVES: The primary aim of this study is to investigate the safety and efficacy of administering an interval, high dose oral vitamin D supplementation in pediatric patients with IBD treated with Remicade. A secondary aim is to study the association between changes in serum 25OHD (25-hydroxyvitamin D3) levels and clinical and biochemical markers of IBD. The findings from this study will provide preliminary data for future studies using serial measurements of serum 25OHD levels to better articulate the optimal dosage for interval vitamin D supplementation in pediatric patients with IBD.
METHODS: We identified and screened pediatric patients with IBD at Boston Children’s Hospital (BCH) with vitamin D deficiency (serum 25OHD level < 30 ng/mL). Vitamin D dosing was determined by a patient’s Remicade interval. Patients received either 50,000 international units (IU) of vitamin D3 (every 4-5 weeks) or 100,000 IU of vitamin D3 (every 6-8 weeks), concurrent with their Remicade infusion interval. Longitudinal data, including anthropomorphic measurements, serum chemistry labs, spot urine calcium to creatinine ratios, quality of life metrics, and surveys gauging dietary vitamin D intake and sunlight exposure, were collected throughout the study.
RESULTS: Baseline vitamin D status in the 60 enrolled patients did not differ by gender, dosing group, diet, or diagnosis (Crohn disease, ulcerative colitis, or indeterminate colitis). Of the 57 patients for whom baseline and final serum 25OHD levels were available, there was a significant increase in total serum 25OHD levels from 22.53 ± 4.65 ng/mL to 29.91 ± 6.60 ng/mL, respectively. Similarly, increases in mean serum 25OHD levels were noted in both dosing formats and disease groups. Interestingly, there was no significant parallel impact of increased 25OHD levels on either disease activity or quality of life. There were no significant changes in serum calcium, phosphorous, and creatinine levels in response to changes in 25OHD levels. There were no reports of significant adverse events related to vitamin D supplementation.
CONCLUSION: High dose, interval vitamin D supplementation improved vitamin D status from baseline in a majority of studied pediatric patients with IBD. The data suggest that this type of interval, high dose format is likely more effective than more traditionally once-daily dosing. Further studies are necessary to determine the optimal dosage regimens optimal in further increasing vitamin D status and to assess for its impact on clinical management.
| Identifer | oai:union.ndltd.org:bu.edu/oai:open.bu.edu:2144/41274 |
| Date | 09 July 2020 |
| Creators | Johansen, Camille E. T. |
| Contributors | Garcia-Diaz, Fernando |
| Source Sets | Boston University |
| Language | en_US |
| Detected Language | English |
| Type | Thesis/Dissertation |
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