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

Официальное название

Randomized, Double-blind, Placebo-controlled Study With 12 Weeks Oral Supplementation With a Formulation Based on Cetylated Fatty Acids to Support the Early Stage of Long Lower Limb Bone Healing After Fracture Stabilization

Обзор

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.

Вмешательства

• Пищевая добавка CFA-based food supplement
  oral gel containing cetilated fatty acids
• Другое Placebo
  oral gel coloured and flavoured as the IP

Первичные конечные точки

• Radiographic Assessment of Callus Formation using the modified Radiographic Union Score for Tibia (mRUST). [Срок оценки: 6 weeks after fracture stabilization]

Вторичные конечные точки (12)

• Pain Assessment at Fracture Site using the Visual Analog Scale (VAS) [Срок оценки: 4 weeks after fracture stabilization]
• Ultrasonographic Assessment of Callus Formation [Срок оценки: 4 weeks after fracture stabilization]
• Radiographic Assessment of Callus Formation (modified Radiographic Union Score for Tibia - mRUST) [Срок оценки: 12 weeks after fracture stabilization]
• Pain Assessment at Fracture Site (Visual Analog Scale - VAS) [Срок оценки: 12 weeks after fracture stabilization]
• Incidence of Complications [Срок оценки: 4 weeks and 12 weeks after fracture stabilization]
• Minimal Clinically Important Improvement (MCII) [Срок оценки: 4 weeks and 12 weeks after fracture stabilization]
• Participant Acceptable Symptom State (PASS) [Срок оценки: 4 weeks and 12 weeks after fracture stabilization]
• Participant Global Assessment (PGA) [Срок оценки: 4 weeks and 12 weeks after fracture stabilization]
• Lower Extremity Functional Scale (LEFS) [Срок оценки: 4 weeks and 12 weeks after fracture stabilization]
• Quality of Life using the Short Form-36 (SF-36) questionnaire. [Срок оценки: 4 weeks and 12 weeks after fracture stabilization]
• Painkiller and NSAID Consumption [Срок оценки: 4 weeks and 12 weeks after fracture stabilization]
• Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [Срок оценки: 4 weeks and 12 weeks after fracture stabilization]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 6 центров

• AZ Monica — Deurne
• Algemeen Ziekenhuis Herentals — Herentals
• Hôpital Erasme - Cliniques Universitaires de Bruxelles — Brussels
• Universitair Ziekenhuis Brussel — Brussels
• Universitair Ziekenhuis Gent — Ghent
• Ziekenhuis Oost-Limburg — Genk

Идентификаторы

NCT: NCT07299851 · CETI ULTRA-BONE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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