The effect of a single early high-dose Vitamin D supplement on fracture union in patients with hypovitaminosis D

A prospective randomised trial

Nikkole Haines, L. B. Kempton, R. B. Seymour, M. J. Bosse, C. Churchill, K. Hand, J. R. Hsu, D. Keil, J. Kellam, N. Rozario, S. Sims, M. A. Karunakar

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1520-1525
Number of pages6
JournalBone and Joint Journal
Volume99B
Issue number11
DOIs
StatePublished - Nov 1 2017

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Vitamin D
Cholecalciferol
Lost to Follow-Up
Bone Fractures
Control Groups
Placebos
Demography
Intention to Treat Analysis
Wounds and Injuries
Random Allocation
Therapeutics
Infection
Serum

All Science Journal Classification (ASJC) codes

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

Haines, Nikkole ; Kempton, L. B. ; Seymour, R. B. ; Bosse, M. J. ; Churchill, C. ; Hand, K. ; Hsu, J. R. ; Keil, D. ; Kellam, J. ; Rozario, N. ; Sims, S. ; Karunakar, M. A. / The effect of a single early high-dose Vitamin D supplement on fracture union in patients with hypovitaminosis D : A prospective randomised trial. In: Bone and Joint Journal. 2017 ; Vol. 99B, No. 11. pp. 1520-1525.
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title = "The effect of a single early high-dose Vitamin D supplement on fracture union in patients with hypovitaminosis D: A prospective randomised trial",
abstract = "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.",
author = "Nikkole Haines and Kempton, {L. B.} and Seymour, {R. B.} and Bosse, {M. J.} and C. Churchill and K. Hand and Hsu, {J. R.} and D. Keil and J. Kellam and N. Rozario and S. Sims and Karunakar, {M. A.}",
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Haines, N, Kempton, LB, Seymour, RB, Bosse, MJ, Churchill, C, Hand, K, Hsu, JR, Keil, D, Kellam, J, Rozario, N, Sims, S & Karunakar, MA 2017, 'The effect of a single early high-dose Vitamin D supplement on fracture union in patients with hypovitaminosis D: A prospective randomised trial', Bone and Joint Journal, vol. 99B, no. 11, pp. 1520-1525. https://doi.org/10.1302/0301-620X.99B11.BJJ-2017-0271.R1

The effect of a single early high-dose Vitamin D supplement on fracture union in patients with hypovitaminosis D : A prospective randomised trial. / Haines, Nikkole; Kempton, L. B.; Seymour, R. B.; Bosse, M. J.; Churchill, C.; Hand, K.; Hsu, J. R.; Keil, D.; Kellam, J.; Rozario, N.; Sims, S.; Karunakar, M. A.

In: Bone and Joint Journal, Vol. 99B, No. 11, 01.11.2017, p. 1520-1525.

Research output: Contribution to journalArticle

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, Nikkole

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.

PY - 2017/11/1

Y1 - 2017/11/1

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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M3 - Article

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SP - 1520

EP - 1525

JO - Bone and Joint Journal

JF - Bone and Joint Journal

SN - 2049-4394

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ER -