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

Caen University Hospital

Status and phase: Unknown; Phase 3

Conditions: Digital Nerve Injury

Treatments: Drug: Placebos; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT04115982

17-237

2018-001526-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Cholecalciferol

Experimental group

Description:

Cholecalciferol (Vitamin D3) 100 000 IU/2 mL

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Description:

Placebo of Cholecalciferol (Vitamine D3) 100 000 IU/2 mL

Treatment:

Drug: Placebos