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

Last updated: August 30, 2021
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04115982
17-237
2018-001526-26
  • Ages 18-51
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Affiliated to social security scheme,
  • Wound of the palmar hand with isolated digital nerve section, requiring digital nervemicrosurgical suture in the operating room by a senior surgeon,
  • Signing a free and informed consent and well-informed of the study and procedure.

Exclusion

Exclusion Criteria:

  • Ischemia,
  • Multiple lesion of the same nerve,
  • Pregnant or nursing women,
  • Contraindication of Cholecalciferol : known hypersensitivity, any history ofhypercalcemia, 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 orpsychological reason,
  • Participation in another clinical trial that does not allow simultaneous participationin several clinical trials,
  • Orlistat® Treatment,
  • History of celiac disease.

Study Design

Total Participants: 72
Study Start date:
January 20, 2020
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Caen University Hospital

    Caen, 14000
    France

    Active - Recruiting

  • Rouen University Hospital

    Rouen, 76000
    France

    Active - Recruiting

  • Institut de la main Nantes Atlantique

    Saint-Herblain, 44800
    France

    Active - Recruiting

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