Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT07299851
Eligibility Criteria:
Inclusion Criteria:
* Between 18 and 85 years old
* Presence of simple closed unifocal fracture (transverse, oblique, spiral, butterfly-shaped) in a long bone which need a standard of care surgical stabilization
* Presence of diaphyseal fracture of lower limb (femur or tibia, Subtrochanteric fracture are also allowed)
* Presence intramedullary nail
* Weight bearing as tolerated after surgery
* Having signed an informed consent, understand study procedures and ability to follow them
* Agreed to stop vitamin D intake for participants who take prophylactic Vitamin D
Exclusion Criteria:
* Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)
* BMI \> 30
* Open fracture
* Intra articular fracture
* Metaphyseal fracture
* Polytrauma patient (injury severity score: ISS \>= 16)
* More than one lower limb long bone fracture
* Bridging plate
* Fracture treated conservatively with plaster
* Presence of active infection (body temperature ≥ 38°C or other symptoms)
* Any sign of severe vascular compromise across the fracture site (such as compartment syndrome, presence of serious vascular damage, etc.)
* Pathological fracture or diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
* Participants with known bone disease which would negatively impact on the bone healing process
* Participants currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy
* Diabetic participants
* Daily smoker participants (cigarette or vaping containing nicotine)
* Participants under cortisone intake
* Participants under rheumatic medications intake
* Allergy or adverse effect of food supplement composition
* Unwilling or unable to take study medication
* Chronic drug or alcohol abuse
* Pregnant or breastfeeding at the time of enrolment
* Any other investigational treatment or food supplement within 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07299851
Study Brief:
Protocol Section:
NCT07299851