OR45-6 High Dose Vitamin D2 Supplementation for a Year Does Not Cause Serious Adverse Events Including Emergency Room Visits and Hospitalizations in African American Men with High Burden of Chronic Disease

Program: Abstracts - Orals, Poster Previews, and Posters
Session: OR45-What Is New in Vitamin D?
Clinical/Translational
Sunday, March 8, 2015: 9:30 AM-11:00 AM
Presentation Start Time: 10:45 AM
Room 29 (San Diego Convention Center)
Chizelle Onochie, Undergraduate student1, Irina Ciubotaru, MD, PhD2, Angela Domenico, undergraduate student1, Yuval Eisenberg, MD2, Subhash C Kukreja, MD2, Arfana Kouser, MD3 and Elena Barengolts, MD3
1University of Illinois at Chicago, 2UIC Section of Endocrinology, Chicago, IL, 3Jesse Brown VAMC, Chicago, IL
BACKGROUND: The observational studies suggest association between higher levels of 25-hydroxyvitamin D [25(OH)D >36 ng/ml) and the risk of cardiovascular disease and all-cause mortality. There are no detailed reports of serious adverse events (SAEs) from long-term randomized controlled trials (RCT) using high doses of vitamin D supplementation.

OBJECTIVE: The aim of this study was to assess long-term safety of high dose vitamin D2 (ergocalciferol) supplementation.

METHODS: We collected SAEs (emergency room visits and hospitalizations) for subjects in RCT of vitamin D Intervention at VA (DIVA, NCT01375660). In DIVA African American male (AAM) veterans with dysglycemia (HbA1C 5.7-6.9%, no anti-diabetes medications) and hypovitaminosis D [25(OH)D 5-29 ng/ml] were randomized to receive placebo (PL) or 50,000 IU vitamin D2 (VD) for a year.  In addition, all men received 400 IU D3 (cholecalciferol) daily. The SAEs were collected at three time points: a year prior (T0), a year of the trial (T1), and a year after the trial (T2). The Chi-square analysis was used to compare SAEs frequencies.

RESULTS: Overall 173 subjects (N=86 in PL and N=87 in VD) completed the trial. Disease burden was relatively high, averaging 4 medical conditions (range 0 - 8) and 6.5 (range 0 - 17) medications per person, respectively, as well as 2.1 Charlson index of chronic disease. The mean [SD] D2 dose was 62,762 [10,772] (range 50,000 - 88,460 IU per week). At baseline serum 25(OH)D (ng/ml) was similar in both groups, PL vs VD 14 [4.8] vs 14.7 [4.7], while at study completion 25(OH)D was significantly lower in PL vs VD 19.9 [7.3] vs 48.1 [18.4] (p<0.001) (overall range 6 - 109 ng/ml). A total of 335 SAEs (119 hospitalizations and 216 emergency room visits) over a 3-year period were equally distributed among T0 (N=110), T1 (n=112) and T2 (N=113). On average there were 23 hospitalizations and 42 emergency room visits per 100 subjects per year. There was no difference in SAEs between PL vs VD groups at any time point: T0 55% vs 45% (p=0.34); T1 46% vs 54% (p=0.34); and T2 50% vs 50% (p=0.45). The most common SAE-related conditions were musculoskeletal (26%), psychiatric (21%), respiratory (13%) and cardiovascular (10%). There were no differences in the SAEs reasons between PL and VD groups and no SAEs were deemed related to vitamin D supplementation.

DISCUSSION: We found high frequency of hospitalizations and emergency room visits in subjects of DIVA trial, that were two-fold higher than those reported by CDC for non-Federal acute care hospitals. Despite of DIVA trial subjects being at high risk for SAEs, high dose vitamin D treatment resulting in relatively high serum 25(OH)D levels did not cause excessive SAEs during active period of treatment or during extended follow up.

CONCLUSION: High dose vitamin D2 supplementation for a year was efficacious and safe for treating hypovitaminosis D in African American men with high burden of chronic disease.

Nothing to Disclose: CO, IC, AD, YE, SCK, AK, EB

*Please take note of The Endocrine Society's News Embargo Policy at https://www.endocrine.org/news-room/endo-annual-meeting

Sources of Research Support: The study was supported by a Merit Review grant funded by the Department of Veterans Affairs, Jesse Brown VA Medical Center and in part by NIH grant number UL1RR029879
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