Vitamin D3 in Sensory Recovery After Digital NERVe Suture: a Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- University Hospital, Caen
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- Weber test (Month 6)
Study Overview
Brief Summary
Digital nerve injuries are frequent in a FESUM center (Federation Européenne des Services d'Urgences Mains), and they need to be repaired in order to reduce the risk of hypoesthesia and to prevent painful neuroma. Several animal studies have shown that Cholecalciferol improves axonal nerve regeneration and myelination. No study has ever been done on human subjects to evaluate the nerve regeneration after Cholecalciferol supplementation.
Our hypothesis is that Cholecalciferol supplementation could improve axonal nerve regeneration and myelination after traumatic digital nerve injuries treated by microsurgical sutures and reduce the risk of hypoesthesia and neuroma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 51 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Affiliated to social security scheme,
- •Wound of the palmar hand with isolated digital nerve section, requiring digital nerve microsurgical suture in the operating room by a senior surgeon,
- •Signing a free and informed consent and well-informed of the study and procedure.
Exclusion Criteria
- •Ischemia,
- •Multiple lesion of the same nerve,
- •Pregnant or nursing women,
- •Contraindication of Cholecalciferol : known hypersensitivity, any history of hypercalcemia, hypercalciuria or renal lithiasis,
- •Cholecalciferol supplementation in the past 6 months,
- •Lesion of the same controlateral finger,
- •History of nerve lesion or hypoesthesia on the same finger,
- •History of previous neurological disorders with upper limb sensitivity disorder,
- •Impossibility to undergo the medical follow-up because of geographical, social or psychological reason,
- •Participation in another clinical trial that does not allow simultaneous participation in several clinical trials,
- •Orlistat® Treatment,
- •History of celiac disease.
Arms & Interventions
Cholecalciferol
Cholecalciferol (Vitamin D3) 100 000 IU/2 mL
Intervention: Cholecalciferol (Drug)
Placebo
Placebo of Cholecalciferol (Vitamine D3) 100 000 IU/2 mL
Intervention: Placebos (Drug)
Outcomes
Primary Outcomes
Weber test (Month 6)
Time Frame: Month 6
2 point discrimination test of Weber on the side of the fingertip concerned by the wound, comparing to the controlateral arm, after 6 months.
Secondary Outcomes
- Cold Intolerance at work(Month 2, Month 6, Month 12)
- Return-to-work time frames(Month 2)
- Weber test (Month 12)(Month 12)
- Cold Intolerance(Month 2, Month 6, Month 12)
- Quality-of-life measure(Month 2, Month 6, Month 12)
- Vitamin D blood level(at inclusion, Month 2)
- Adverse event and complication(Trough study completion)
- Resting pain on the operated finger(Month 2, Month 6, Month 12)
- Neuropathic pain on the operated finger(Month 2, Month 6, Month 12)
- Global functional outcome measure(Month 2, Month 6, Month 12)