Clinical trial · Interventional
Vitamin D3 in Sensory Recovery After Digital NERVe Suture (D3NERV).
Vitamin D3 in Sensory Recovery After Digital NERVe Suture: a Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digital Nerve Injury | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cholecalciferol | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cholecalciferol
- description
- Cholecalciferol (Vitamin D3) 100 000 IU/2 mL
- interventionNames
- Drug: Cholecalciferol
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo of Cholecalciferol (Vitamine D3) 100 000 IU/2 mL
- interventionNames
- Drug: Placebos
Primary outcomes (1)
- measure
- Weber test (Month 6)
- timeFrame
- Month 6
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 51 Years
Show eligibility criteria text
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.
References
Publications (26)
- BACKGROUNDal-Ghazal SK, McKiernan M, Khan K, McCann J. Results of clinical assessment after primary digital nerve repair. J Hand Surg Br. 1994 Apr;19(2):255-7. doi: 10.1016/0266-7681(94)90180-5. PMID 8014564
- BACKGROUNDAlligand-Perrin P, Rabarin F, Jeudy J, Cesari B, Saint-Cast Y, Fouque PA, Raimbeau G. Vein conduit associated with microsurgical suture for complete collateral digital nerve severance. Orthop Traumatol Surg Res. 2011 Jun;97(4 Suppl):S16-20. doi: 10.1016/j.otsr.2011.03.012. Epub 2011 Apr 30. PMID 21531189
- BACKGROUNDArnaout A, Fontaine C, Chantelot C. Sensory recovery after primary repair of palmar digital nerves using a Revolnerv((R)) collagen conduit: a prospective series of 27 cases. Chir Main. 2014 Sep;33(4):279-85. doi: 10.1016/j.main.2014.05.002. Epub 2014 Jun 18. PMID 25169199
- BACKGROUNDBarrueto F Jr, Wang-Flores HH, Howland MA, Hoffman RS, Nelson LS. Acute vitamin D intoxication in a child. Pediatrics. 2005 Sep;116(3):e453-6. doi: 10.1542/peds.2004-2580. PMID 16140692
- BACKGROUNDBattiston B, Geuna S, Ferrero M, Tos P. Nerve repair by means of tubulization: literature review and personal clinical experience comparing biological and synthetic conduits for sensory nerve repair. Microsurgery. 2005;25(4):258-67. doi: 10.1002/micr.20127. PMID 15934044
- BACKGROUNDBertleff MJ, Meek MF, Nicolai JP. A prospective clinical evaluation of biodegradable neurolac nerve guides for sensory nerve repair in the hand. J Hand Surg Am. 2005 May;30(3):513-8. doi: 10.1016/j.jhsa.2004.12.009. PMID 15925161
- BACKGROUNDChabas JF, Stephan D, Marqueste T, Garcia S, Lavaut MN, Nguyen C, Legre R, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D(3)) improves myelination and recovery after nerve injury. PLoS One. 2013 May 31;8(5):e65034. doi: 10.1371/journal.pone.0065034. Print 2013.