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

Digital Nerve Injury Clinical Trial

— D3NERV  

Official title:

Vitamin D3 in Sensory Recovery After Digital NERVe Suture: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04115982
• Other study ID #: 17-237
• Secondary ID: 2018-001526-26
• Status: Recruiting
• Phase: Phase 3
• Start date: January 20, 2020
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: University Hospital, Caen
• Contact: Flore-Anne Lecoq, MD
• Phone: +33251848884
• Email: flore.lecoq[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 51 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digital Nerve Injury

Intervention

Drug:
• Cholecalciferol
One vial every 15 days during 2 months
• Placebos
One vial every 15 days during 2 months

Locations

Country	Name	City	State
France	Caen University Hospital	Caen
France	Rouen University Hospital	Rouen
France	Institut de la main Nantes Atlantique	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (26)

al-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. — View Citation

Alligand-Perrin P, Rabarin F, Jeudy J, Césari 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. — View Citation

Arnaout A, Fontaine C, Chantelot C. Sensory recovery after primary repair of palmar digital nerves using a Revolnerv(®) 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. — View Citation

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Battiston 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. Review. — View Citation

Bertleff 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. — View Citation

Chabas JF, Stephan D, Marqueste T, Garcia S, Lavaut MN, Nguyen C, Legre R, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D3) improves myelination and recovery after nerve injury. PLoS One. 2013 May 31;8(5):e65034. doi: 10.1371/journal.pone.0065034. Print 2013. — View Citation

Fakin RM, Calcagni M, Klein HJ, Giovanoli P. Long-term clinical outcome after epineural coaptation of digital nerves. J Hand Surg Eur Vol. 2016 Feb;41(2):148-54. doi: 10.1177/1753193415578986. Epub 2015 Mar 31. — View Citation

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Gueye Y, Marqueste T, Maurel F, Khrestchatisky M, Decherchi P, Feron F. Cholecalciferol (vitamin D3) improves functional recovery when delivered during the acute phase after a spinal cord trauma. J Steroid Biochem Mol Biol. 2015 Nov;154:23-31. doi: 10.1016/j.jsbmb.2015.06.007. Epub 2015 Jul 6. — View Citation

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Manoli T, Schiefer JL, Schulz L, Fuchsberger T, Schaller HE. Influence of immobilization and sensory re-education on the sensory recovery after reconstruction of digital nerves with direct suture or muscle-in-vein conduits. Neural Regen Res. 2016 Feb;11(2):338-44. doi: 10.4103/1673-5374.169638. — View Citation

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Pomares G, Dap F, Dautel G. Complete section of proper palmar digital pedicles: Correlation between arterial patency and sensory recovery. Hand Surg Rehabil. 2017 Apr;36(2):136-140. doi: 10.1016/j.hansur.2016.12.001. Epub 2017 Mar 9. — View Citation

Przybelski R, Agrawal S, Krueger D, Engelke JA, Walbrun F, Binkley N. Rapid correction of low vitamin D status in nursing home residents. Osteoporos Int. 2008 Nov;19(11):1621-8. doi: 10.1007/s00198-008-0619-x. Epub 2008 Apr 18. — View Citation

Romagnoli E, Mascia ML, Cipriani C, Fassino V, Mazzei F, D'Erasmo E, Carnevale V, Scillitani A, Minisola S. Short and long-term variations in serum calciotropic hormones after a single very large dose of ergocalciferol (vitamin D2) or cholecalciferol (vitamin D3) in the elderly. J Clin Endocrinol Metab. 2008 Aug;93(8):3015-20. doi: 10.1210/jc.2008-0350. Epub 2008 May 20. — View Citation

Shimokata H, Kuzuya F. Two-point discrimination test of the skin as an index of sensory aging. Gerontology. 1995;41(5):267-72. — View Citation

Shooter D. Use of two-point discrimination as a nerve repair assessment tool: preliminary report. ANZ J Surg. 2005 Oct;75(10):866-8. — View Citation

Taylor PN, Davies JS. A review of the growing risk of vitamin D toxicity from inappropriate practice. Br J Clin Pharmacol. 2018 Jun;84(6):1121-1127. doi: 10.1111/bcp.13573. Epub 2018 Apr 16. Review. — View Citation

Vieth R, Chan PC, MacFarlane GD. Efficacy and safety of vitamin D3 intake exceeding the lowest observed adverse effect level. Am J Clin Nutr. 2001 Feb;73(2):288-94. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Month 12
Secondary	Resting pain on the operated finger	VAS (Visual Analogic Scale)	Month 2, Month 6, Month 12
Secondary	Neuropathic pain on the operated finger	DN 4 (Neuropathic pain)	Month 2, Month 6, Month 12
Secondary	Global functional outcome measure	Quick DASH	Month 2, Month 6, Month 12
Secondary	Cold Intolerance	CSS (Cold Sensitivity Severity Scale)	Month 2, Month 6, Month 12
Secondary	Cold Intolerance at work	PWES (Potential Work Exposure Scale)	Month 2, Month 6, Month 12
Secondary	Quality-of-life measure	SF-36 (Study Short form 36)	Month 2, Month 6, Month 12
Secondary	Return-to-work time frames	Time before returning to work	Month 2
Secondary	Vitamin D blood level		at inclusion, Month 2
Secondary	Adverse event and complication	Existence of neuroma, existence of medical complication, existence of overdosage of Cholecalciferol and every other adverse event	Trough study completion