TY - JOUR
T1 - The effect of a single early high-dose Vitamin D supplement on fracture union in patients with hypovitaminosis D
T2 - A prospective randomised trial
AU - Haines, N.
AU - Kempton, L. B.
AU - Seymour, R. B.
AU - Bosse, M. J.
AU - Churchill, C.
AU - Hand, K.
AU - Hsu, J. R.
AU - Keil, D.
AU - Kellam, J.
AU - Rozario, N.
AU - Sims, S.
AU - Karunakar, M. A.
N1 - Funding Information:
The research was supported by an internal peer-reviewed grant from the Carolinas HealthCare Cannon Research Fund.
PY - 2017/11
Y1 - 2017/11
N2 - Aims To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Patients and Methods Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D3 orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled followup were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. Results In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Conclusions Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D3.
AB - Aims To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Patients and Methods Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D3 orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled followup were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. Results In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Conclusions Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D3.
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U2 - 10.1302/0301-620X.99B11.BJJ-2017-0271.R1
DO - 10.1302/0301-620X.99B11.BJJ-2017-0271.R1
M3 - Article
C2 - 29092993
AN - SCOPUS:85033552297
SN - 2049-4394
VL - 99B
SP - 1520
EP - 1525
JO - Bone and Joint Journal
JF - Bone and Joint Journal
IS - 11
ER -