Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair

NCT06384833 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Rama
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are: Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair. Participants will: Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests.

Conditions

Rotator Cuff Tears

Keywords

Ascorbic acid; Acetylcysteine; Rotator cuff repair

Outcome Measures

Primary Outcomes (1)

• ASES score

  American Shoulder and Elbow Surgeons (ASES) Shoulder Score

  6 months after surgery

Secondary Outcomes (3)

• UCLA shoulder scale

  6 months after surgery

• WORC index

  6 months after surgery

• Tendon healing at 6 months postoperatively

  6 months after surgery

Study Arms (2)

Ascorbic Acid and N-acetylcysteine

EXPERIMENTAL

Vitamin C 500 mg IV q4h for 4 doses PO d0 N-acetylcysteine 600mg 1 tab PO OD for 45 days Vitamin C 100mg 5 tab PO BID for 45 days

Drug: Ascorbic acid; Drug: N-acetyl cysteine

Placebo

PLACEBO COMPARATOR

Placebo of vitamin C (0.9%NaCl) 100 ml IV q4h for 4 doses PO day0 Placebo of N-acetylcysteine 1 tab PO OD for 45 days Placebo of Vitamin C 5 tab PO BID for 45 days

Other: placebo

Interventions

Ascorbic acid DRUG

Vitamin C (solution) 500 mg IV q4h for 4 doses PO d0 Vitamin C (tablet) 100mg 5 tab PO BID for 45 days

Also known as: Vitamin C

Ascorbic Acid and N-acetylcysteine

N-acetyl cysteine DRUG

NAC (effervescent) 600mg 1 tab PO OD for 45 days

Also known as: NAC

Ascorbic Acid and N-acetylcysteine

placebo OTHER

pharmacologically inactive substance

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient who undergone arthroscopic primary rotator cuff complete repair.
• Clinical history and symptom consistent with rotator cuff tear.
• MRI confirmation of rotator cuff tear.

You may not qualify if:

• Non-reparable or partial rotator cuff repair.
• High grade fatty degeneration of the rotator cuff (Goutallier III, IV)
• At least one torn tendon with retraction to the glenoid (stage 3 of Patte classification)
• Rotator cuff retear.
• Isolated subscapularis tear.
• Patient who loss follow up.
• Patent who cannot respond questionnaire.
• Patient who allergy to vitamin C or N-acetylcysteine.

Sponsors & Collaborators

• Mahidol University: lead

Related Publications (3)

• Uehara H, Itoigawa Y, Morikawa D, Koga A, Tsurukami H, Maruyama Y, Ishijima M. The Effect of Vitamin C and N-Acetylcysteine on Tendon-to-Bone Healing in a Rodent Model of Rotator Cuff Repair. Am J Sports Med. 2023 May;51(6):1596-1607. doi: 10.1177/03635465231160772. Epub 2023 Apr 5.

  PMID: 37017249 BACKGROUND

• Gilat R, Atoun E, Cohen O, Tsvieli O, Rath E, Lakstein D, Levy O. Recurrent rotator cuff tear: is ultrasound imaging reliable? J Shoulder Elbow Surg. 2018 Jul;27(7):1263-1267. doi: 10.1016/j.jse.2017.12.017. Epub 2018 Feb 3.

  PMID: 29398398 BACKGROUND

• Martel M, Laumonerie P, Girard M, Dauzere F, Mansat P, Bonnevialle N. Does vitamin C supplementation improve rotator cuff healing? A preliminary study. Eur J Orthop Surg Traumatol. 2022 Jan;32(1):63-70. doi: 10.1007/s00590-021-02926-0. Epub 2021 Mar 16.

  PMID: 33725178 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Ascorbic Acid; Acetylcysteine

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 25, 2024
• Study Start: May 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share