]>
IRCT20250825066991N1 IRCT 2025-09-23 Iran University of Medical Sciences "The effect of vitamin C on the treatment of torn rotator cuff injuries. The Effect of Ascorbic Acid (Vitamin C) on Functional Recovery and Pain relief Following Open Rotator Cuff Repair: A Randomized Clinical Tria 2025-09-23 anticipated 64 Recruiting https://irct.ir/trial/85804 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: "In the intervention group, an oral vitamin C supplement at a daily dose of 500 mg will be administered starting from the first postoperative day and continued for six weeks. The selected brand is Nature Made®. The aim of this intervention is to enhance tendon healing and reduce the risk of re-tear, based on findings from recent studies, Randomization description: Patients will be randomly assigned to either the intervention or control group using block randomization implemented through specialized software. In block randomization, a predetermined number of patients (e.g., multiples of 4 or 6) are grouped into blocks, and the allocation sequence within each block is randomly generated to ensure balanced group sizes. This method helps maintain an approximately equal number of participants in both groups throughout the study, Blinding description: To ensure a double-blind study design, the supplement and placebo were manufactured to be identical in appearance, taste, and packaging. Each product was labeled with a unique code rather than a name, and these codes were accessible only to the pharmacist or principal investigator. The codes remained concealed until the end of the study. Consequently, neither the patients nor the clinical team, evaluators, or statistical analysts were aware of the type of intervention administered. 3 Rotator Cuff Tear. Intervention 1: Intervention group: Participants in the intervention group will receive an oral vitamin C supplement at a daily dose of 500 mg, starting from the first day after surgery and continuing for a duration of six weeks. The selected brand for supplementation is Nature Made®. Intervention 2: Control group: The group that receives the placebo. Yes - There is a plan to make this available What will be shared: Participant Data File Informed Consent Form When: Access to the resources will commence at the end of the Iranian calendar year 1406, corresponding approximately to March 2028. To whom: for all people Conditions: All individuals requesting to review the rotator cuff data are granted access to the dataset. Permission is hereby granted for the performance of all statistical analyses on the data. Furthermore, individuals are permitted to utilize this data in their own studies, provided that proper citation and reference is made to the original publication. Where to obtain: Iran University of Medical Sciences Research Department Adjacent to Milad Tower, Hemmat Highway Tehran, Iran Postal Code: 1449614535 Tel: (+98 21) 86701 Email: info@iums.ac.ir How to obtain: Following correspondence with the Research Department of Iran University of Medical Sciences, access to the dataset will be granted within one business week. Comments:
public Alireza Ebadi
No. 50, 2nd Floor, Golestani Alley, Taslihat Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1651697111 +98 935 998 4298 dr.alirezaebadi@gmail.com Iran University of Medical Sciences scientific Alireza Ebadi
No. 50, 2nd Floor, Golestani Alley, Taslihat Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1651697111 +98 935 998 4298 dr.alirezaebadi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients over the age of 18 undergoing open surgical repair for rotator cuff tears Confirmation of full-thickness tear in one or more rotator cuff tendons based on preoperative MRI assessment and intraoperative verification. "Provision of written informed consent to participate in the study and commitment to postoperative follow-up according to the specified schedule Adequate general health status to undergo the standard postoperative treatment and rehabilitation process 18 years no limit Both Shoulder Revision Surgery "Presence of neurological or muscular disorders that may affect shoulder functional outcomes (e.g., neuromuscular diseases) Presence of significant concomitant injuries to other shoulder structures (e.g., extensive glenoid labrum tear or advanced glenohumeral joint osteoarthritis) "Pregnancy or the presence of uncontrolled systemic diseases such as uncontrolled diabetes mellitus or advanced renal failure M75.12 Complete rotator cuff tear or rupture not specified as traumatic Treatment - Drugs Placebo Intervention group: Participants in the intervention group will receive an oral vitamin C supplement at a daily dose of 500 mg, starting from the first day after surgery and continuing for a duration of six weeks. The selected brand for supplementation is Nature Made®. Control group: The group that receives the placebo Determination of the mean (± standard deviation) scores of upper limb function (QuickDASH) in the ascorbic acid intervention group and the control group. Timepoint: Week 12 and Week 24. Method of measurement: QuickDASH Questionnaire. Comparison of mean upper limb functional scores (QuickDASH) between the ascorbic acid intervention group and the control group. Timepoint: Week 12 and Week 24 after surgery. Method of measurement: QuickDASH Questionnaire. Etermination of the mean (± standard deviation) pain intensity scores in the ascorbic acid intervention group and the control group. Timepoint: At weeks 2, 6, 12, and 24 following the surgery. Method of measurement: Visual Analogue Scale Questionnaire. Comparison of the Mean Pain Intensity Between the Ascorbic Acid Group and the Control Group. Timepoint: At weeks 2, 6, 12, and 24 following the surgery. Method of measurement: Visual Analogue Scale Questionnaire. Determination of the Mean (Standard Deviation) of Shoulder Joint Range of Motion (ROM) in the Ascorbic Acid Group and the Control Group. Timepoint: Weeks 12 and 24 following the surgery. Method of measurement: Using an instrument called a goniometer. Comparison of the Mean Shoulder Joint Range of Motion (ROM) Between the Ascorbic Acid Group and the Control Group. Timepoint: Weeks 12 and 24 following the surgery. Method of measurement: Using an instrument called a goniometer. Iran University of Medical Sciences Approved 2025-08-14 Ethics Committee of the School of Medicine, Iran University of Medical Sciences. Iran University of Medical Sciences Adjacent to Milad Tower, Hemmat Highway Tehran, Iran Tehran Tehran Iran (Islamic Republic of)