Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-09 @ 4:15 AM
Study NCT ID:
NCT06384833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASES score', 'timeFrame': '6 months after surgery', 'description': 'American Shoulder and Elbow Surgeons (ASES) Shoulder Score'}], 'secondaryOutcomes': [{'measure': 'UCLA shoulder scale', 'timeFrame': '6 months after surgery', 'description': 'The University of California-Los Angeles (UCLA) shoulder scale'}, {'measure': 'WORC index', 'timeFrame': '6 months after surgery', 'description': 'Western Ontario Rotator Cuff Index'}, {'measure': 'Tendon healing at 6 months postoperatively', 'timeFrame': '6 months after surgery', 'description': 'Sugaya ultrasound classification'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ascorbic acid', 'Acetylcysteine', 'Rotator cuff repair'], 'conditions': ['Rotator Cuff Tears']}, 'referencesModule': {'references': [{'pmid': '37017249', 'type': 'BACKGROUND', 'citation': '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': '29398398', 'type': 'BACKGROUND', 'citation': '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': '33725178', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nDo 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.\n\nParticipants will:\n\nTake 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patient who undergone arthroscopic primary rotator cuff complete repair.\n* Clinical history and symptom consistent with rotator cuff tear.\n* MRI confirmation of rotator cuff tear.\n\nExclusion Criteria:\n\n* Non-reparable or partial rotator cuff repair.\n* High grade fatty degeneration of the rotator cuff (Goutallier III, IV)\n* At least one torn tendon with retraction to the glenoid (stage 3 of Patte classification)\n* Rotator cuff retear.\n* Isolated subscapularis tear.\n* Patient who loss follow up.\n* Patent who cannot respond questionnaire.\n* Patient who allergy to vitamin C or N-acetylcysteine.'}, 'identificationModule': {'nctId': 'NCT06384833', 'briefTitle': 'Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair: A Triple-blinded, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Rama'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ascorbic Acid and N-acetylcysteine', 'description': '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', 'interventionNames': ['Drug: Ascorbic acid', 'Drug: N-acetyl cysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Ascorbic acid', 'type': 'DRUG', 'otherNames': ['Vitamin C'], 'description': 'Vitamin C (solution) 500 mg IV q4h for 4 doses PO d0 Vitamin C (tablet) 100mg 5 tab PO BID for 45 days', 'armGroupLabels': ['Ascorbic Acid and N-acetylcysteine']}, {'name': 'N-acetyl cysteine', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': 'NAC (effervescent) 600mg 1 tab PO OD for 45 days', 'armGroupLabels': ['Ascorbic Acid and N-acetylcysteine']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'pharmacologically inactive substance', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}