BACKGROUND: Vitamin D deficiency and insufficiency are rising healthcare concerns in the United States (US) and worldwide. The latest data collected by the National Health and Nutrition Examination Surveys (NHANES) between 2002-2006 showed that approximately one third of Americans over one-year-old were vitamin D deficient (serum 25-hydroxy vitamin D (25-OHD) < 12 ng/mL) or insufficient (serum 25-OHD < 20 ng/mL) (Looker et al., 2011). Environmental exposures, acute or chronic disease, and genetics can exacerbate vitamin D deficiency. People with malabsorptive disorders such as Inflammatory Bowel Disease (IBD) are at an even greater risk of becoming vitamin D deficient. Pediatric patients with IBD are particularly vulnerable to the short and long-term effects of vitamin D deficiency, given the prominent role played by this agent on skeletal development.
More recent data have demonstrated that vitamin D also plays an important role in maintaining and regulating the immune system. For this reason, investigators have been interested in a better understanding of the relationship between vitamin D and inflammation. Vitamin D may prove to be an important adjunct therapy for people suffering from IBD and other autoinflammatory diseases.
OBJECTIVES: Many patients and medical providers understand the importance that vitamin D has in a growing child’s skeletal development. However, compliance with daily supplementation remains low. The design of this study allows patients to receive high-dose vitamin D supplementation during scheduled biologic infusions. The goal is to assess the safety and efficacy of high-dose interval vitamin D therapy. The secondary goal of this study will be to determine if optimal vitamin D levels impact the inflammation observed in the gastrointestinal (GI) tract of patients with IBD.
METHODS: 60 patients with IBD, between 5-25 years of age, who received regularly scheduled infliximab or vedolizumab infusions, and had serum 25-OHD levels below 30 ng/mL were recruited for the study. These patients were screened for the exclusion criteria, including underlying liver or kidney disease. Enrolled participants were given eight high-dose oral vitamin D3 supplements during scheduled infliximab or vedolizumab infusions for 8-16 months. Serum 25-OHD levels, urine calcium and creatinine levels, and research blood samples were collected at baseline, midpoint, and final visits. Questionnaires were also dispensed to patients to measure quality of life (QoL). This data was collected and analyzed to assess the safety and efficacy of high-dose interval vitamin D supplementation in pediatric patients with IBD.
RESULTS: The data from this study showed statistical significance in the change of serum-25OHD level from baseline to midpoint and final visits. The mean increase from baseline to midpoint was 15.71±10.1 ng/mL for the 30 participants who had completed 3 study doses (2,500 mCg or 5,000 mCg) (mean±95% CI). The mean increase from baseline to final visit was 18.1±11.67 ng/mL for the 19 participants who completed all 7 study doses (2,500 mCg or 5,000 mCg) (mean±95% CI). A single factor ANOVA test confirmed statistical significance with p < 0.0001. Urine calcium and creatinine levels did not have a statistically significant change from baseline to final visit for the 12 participants who had completed both samples. Lastly, IMPACT-III QoL scores were not significantly different from baseline. However, there was an overall increase in the mean scores in all 6 subcategories of the survey. As more participants complete the study, the statistical significance and the validity of results will likely be strengthened.
CONCLUSION: High-dose interval vitamin D supplementation was a safe and effective way to achieve serum 25-OHD levels to an optimal range (i.e., 40-60 ng/mL) in pediatric patients and young adult patients with IBD. The data suggests that three doses of high-dose vitamin D may be sufficient to bring levels to an optimal and stable plateau. Patient compliance with supplementation was 100% in this study, because of provider-observed ingestion of vitamin D. Patients also noted that this was their preferred method of supplementation. The safety and efficacy results of this study serve as a framework for developing a more standard approach to vitamin D supplementation for our patients with IBD. Future studies may benefit from expanding this method of delivery to patients who have other inflammatory diseases that require both regular oral vitamin D therapy and in person visits for treatments (i.e., intravenous (IV) medication).
| Identifer | oai:union.ndltd.org:bu.edu/oai:open.bu.edu:2144/48287 |
| Date | 29 February 2024 |
| Creators | Lavoie, Ashley |
| Contributors | Levy, Simon, Rufo, Paul |
| Source Sets | Boston University |
| Language | en_US |
| Detected Language | English |
| Type | Thesis/Dissertation |
| Rights | Attribution 4.0 International, http://creativecommons.org/licenses/by/4.0/ |
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