Vitamin D3 in Sensory Recovery After Digital NERVe Suture (D3NERV).

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D3 in Sensory Recovery After Digital NERVe Suture: a Randomized Controlled Trial.

Conditions
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Digital Nerve Injury

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecalciferol<br>Cholecalciferol (Vitamin D3) 100 000 IU/2 mL | Drug: Cholecalciferol<br>* One vial every 15 days during 2 months<br>|
| Placebo Comparator: Placebo<br>Placebo of Cholecalciferol (Vitamine D3) 100 000 IU/2 mL | Drug: Placebos<br>* One vial every 15 days during 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weber test (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. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weber test (Month 12) | 2 point discrimination test of Weber on the side of the fingertip concerned by the wound, comparing to the controlateral arm, after 12 months. | Month 12 | 
| Resting pain on the operated finger | VAS (Visual Analogic Scale) | Month 2, Month 6, Month 12 | 
| Neuropathic pain on the operated finger | DN 4 (Neuropathic pain) | Month 2, Month 6, Month 12 | 
| Global functional outcome measure | Quick DASH | Month 2, Month 6, Month 12 | 
| Cold Intolerance | CSS (Cold Sensitivity Severity Scale) | Month 2, Month 6, Month 12 | 
| Cold Intolerance at work | PWES (Potential Work Exposure Scale) | Month 2, Month 6, Month 12 | 
| Quality-of-life measure | SF-36 (Study Short form 36) | Month 2, Month 6, Month 12 | 
| Return-to-work time frames | Time before returning to work | Month 2 | 
| Vitamin D blood level |  | at inclusion, Month 2 | 
| Adverse event and complication | Existence of neuroma, existence of medical complication, existence of overdosage of Cholecalciferol and every other adverse event | Trough study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital nerve injury, neuroma, cholecalciferol