The Effect of Vitamin D on the Consolidation of Extra-articular Fractures - a double-blind randomized controlled trial

Background:
A large part of the population has a relative or absolute vitamin D deficiency. Recent, as yet unpublished results show that 70% of the patient population between 18 and 50 years with a fracture has a vitamin D insufficiency (25 (OH) D <75 nmol / L), and 40% has a deficiency (25 (OH) D <50 nmol / L). Vitamin D plays a role in the cellular process of fracture healing. However, the number of available clinical studies on the role of vitamin D on fracture healing is scarce and these studies mainly focus on elderly fracture patients. The clinical effect of vitamin D status and vitamin D supplementation on fracture healing is unknown in the fracture population aged between 18 and 50 years.

Study objectives:
The influence of the initial vitamin D status and the effect of vitamin D supplementation on the fracture consolidation will be studied. An evidence-based recommendation to vitamin D status and vitamin D supplementation in fracture treatment will be based on the study results. Primarily, the effect of vitamin D supplementation on bone healing, the incidence of delayed fracture healing (delayed union) will be investigated in a vitamin D insufficient fracture population. Secondary the effect of vitamin D supplementation on the occurrence of complications , functional outcome, and health-related quality of life will be investigated. We will also examine the influence of the initial vitamin D status on the fracture healing, and conduct a cost-effectiveness analysis on vitamin D supplementation.

Study design:
In this double-blind randomized controlled trial, patients are randomized between 25.000IU Colecalciferol once a month for 4 months and placebo once a month for 4 months. Patients will be seen according to a fixed schedule during which fracture healing will be monitored using radiography, and blood samples will be obtained for determination of the vitamin D status.

Study population:
250 patients aged between 18 and 50 years, with an extra-articular fracture of a long bone (clavicle, humerus, radius, antebrachii, femur, tibia, cruris or Weber A, B or C fracture).

Vitamin D supplementation reduces the incidence of delayed union in fracture patients with a vitamin D insufficiency, compared to placebo.

1, 4, 8, 12, 16, 26 and 52 weeks after fracture.

Group studie medication:
25.000IU Colecalciferol once a month during a period of 4 months.

Group placebo:
Placebo once a month during a period of 4 months.