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

University Hospital, Caen72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Digital Nerve Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 51 Years

Medical Language ↔ Plain English

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.

Locations (3)

Caen University Hospital

Caen, France

RECRUITING

Rouen University Hospital

Rouen, France

RECRUITING

Institut de la main Nantes Atlantique

Saint-Herblain, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Month 6

Secondary Outcomes

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.

Time frame: Month 12

Resting pain on the operated finger

VAS (Visual Analogic Scale)