2.2. Participants
fracture, dysplasia, chronic diseases, fractures, distal radial fracture, Silverman syndrome, trauma
DISEASES, RECURRENCE, OSTEOGENESIS IMPERFECTA, DYSPLASIA, CYSTIC FIBROSIS, CHRONIC DISEASES, SEPARATION
A prospective case-control randomized cross-sectional single-blinded study was conducted between 2018 and 2020. The study included children referred to the clinic for various fractures of the upper and lower extremities. After fracture diagnosis, they were split into two groups: the study group, which included patients that would receive calcium and vitamin D supplements, and the control group, which included patients that would not receive supplements. Another reference cohort comprised patients presented in the pediatric ward for respiratory or gastroenterological conditions without a history of fractures or intake of vitamin D and calcium in the last 6 months. This group was used for age–sex matching tests. Vitamin D and calcium levels were available for all of the patients included in the study. Matching was done for age, gender, and season.Randomization was done with the electronically stored medical registration program by automatically including a patient with a fracture randomly in either the study or the control group; thus, the risk of bias was kept to a minimum (none of the parties knew which group a patient would enter).The working protocol for the patients in the study and control group included the following aspects: patient history, clinical and radiological exam, type of fracture, blood samples for 25-OH-vitamin D and calcium, and follow-up to see the time of healing and fracture recurrence.Patients’ electronic files were classified according to ICD-10 (10th revision of the International Statistical Classification of Diseases and Related Health Problems). Injuries were defined as all trauma presentations with an ICD-10 code in the categories beginning with the letter ‘S’ and then supplemented by the causal code (how the fracture occurred). Four authors examined all data and corrected inconsistencies in the database to reduce errors, such as diagnostic equivalents (i.e., distal radial fracture vs. distal radial epiphyseal separation vs. distal radial Salter–Harris 2 fracture).X-rays were taken on 2 sides (for example, forearm AP and lateral, hand AP, and ¾ or oblique view) and were digitally stored using a high-precision digital system.Inclusion criteria for the study and control group were as follows: age between 2–17 years, fractures of upper and lower limbs, clinical and radiological exam to sustain the diagnosis, follow-up for at least 12 months, 25-OH-vitamin D and calcium blood samples at the time of enrollment in the study and after 6 months of supplementation (only for the study group).Exclusion criteria included age less than 2 years, age above 18 years, abusive trauma (including Silverman syndrome), high-energy trauma mechanisms, child abuse cases, pelvic and spine fractures, patients suffering from chronic diseases affecting bone status (including osteogenesis imperfecta), dysplasia, cystic fibrosis, patients treated with corticosteroids, follow-up for less than 12 months, lack of patient history, missing blood samples, and intake of vitamin D and calcium treatment in the 6 months prior to the study.