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

NCT04115982 | Unknown Phase 3

• 2 other identifiers: 17-2372018-001526-26
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Digital Nerve Injury

Keywords

digital nerve injury; neuroma; cholecalciferol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Weber test (Month 12)

  Month 12

• 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

• Cold Intolerance

  Month 2, Month 6, Month 12

Study Arms (2)

Cholecalciferol

EXPERIMENTAL

Cholecalciferol (Vitamin D3) 100 000 IU/2 mL

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Cholecalciferol DRUG

One vial every 15 days during 2 months

Cholecalciferol

Placebos DRUG

One vial every 15 days during 2 months

Placebo

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (3)

Caen University Hospital

Caen, 14000, France

RECRUITING

Rouen University Hospital

Rouen, 76000, France

RECRUITING

Institut de la main Nantes Atlantique

Saint-Herblain, 44800, France

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Neuroma

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Flore-Anne Lecoq, MD

CONTACT

+33251848884; flore.lecoq@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: October 4, 2019
• Study Start: January 20, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-07

Locations

FR (3)