Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing (CETIULTRA-BONE)

Pharmanutra S.p.a.

Status: Enrolling

Conditions: Fracture Tibia; Fracture Femur

Treatments: Dietary Supplement: CFA-based food supplement; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07299851

CETI ULTRA-BONE

Details and patient eligibility

About

This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs. The investigational product is administered orally over a 12-week period. Study procedures are limited to standard imaging techniques (radiography and echography), blood sampling, and completion of validated quality of life questionnaires.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

CFA-based supplement group

Experimental group

Description:

Participants will orally consume the assigned product for at least 12 weeks. Intake will be initiated from the day of Baseline (Visit 0) after all study procedures being performed until the morning of the last visit (Visit 3). Participants will take 2 sachets a day directly in their mouth.

Treatment:

Dietary Supplement: CFA-based food supplement

Placebo group

Placebo Comparator group

Description:

Participants will orally consume the assigned product for at least 12 weeks. Intake will be initiated from the day of Baseline (Visit 0) after all study procedures being performed until the morning of the last visit (Visit 3). Participants will take 2 sachets a day directly in their mouth.

Treatment:

Other: Placebo