At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Trial Comparing the Effects of 2 Vitamin D Supplementation Regimens in Elderly People After Hip Fracture Surgery
In Brief
A Phase 4 clinical trial evaluating Calcifediol (Vitamin D) for Hip Fracture and Vitamin D Deficiency. Completed, enrolled 50 participants across 1 site.
Detailed Summary
This study will be done to evaluate the effect of load dose of vitamin D compared to the dose of usual clinical practice, in improving mobility and reducing disability in older people following a hip fracture.
Study Details
Timeline
Interventions
After surgical treatment, participants with vitamin D deficiency (25OHD \< 30 ng/mL) will be randomly allocated to an intervention group or control group. For the intervention group, participants will receive 16. 000 U oral Calcifediol daily for 5 days. For the control group, participants will receive 16.000 U oral Calcifediol weekly for 5 weeks. Both groups: 1. Will follow the usual hip fracture rehabilitation pathway. 2. 25OHD serum levels will be measured after 4 weeks. Depending on the serum 25OHD level, the patients will receive different vitamin D strategies (according to the protocol) Patients will be monitored for up to 12 months after the discharge from the hospital, with 3 clinic visits at 3, 6 and 12 months (to determine serum vitamin D levels and to evaluate functional status)