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IRCT20260919071112N1 IRCT 2026-09-25 Oroumia University of Medical Sciences The effect of chia seed in patients with rheumatoid arthritis A study on the effect of chia seed intake inflammatory markers, joint pain severity, body weight and quality of life in patients with rheumatoid arthritis 2026-09-23 anticipated 22 Recruiting https://irct.ir/trial/93504 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients with rheumatoid arthritis will be randomly allocated to two groups: an intervention group and a control group. Participants will be assigned to the groups using a computer-generated random number table and simple randomization, Blinding description: Participants will be randomly allocated to two groups, an intervention group and a control group, using simple randomization. The group allocation and distribution of chia seeds will be carried out by an individual independent of the principal investigator. Based on the randomization list, this individual will provide chia seeds to participants allocated to the intervention group, while no intervention will be provided to participants in the control group. To maintain blinding, the principal investigator will not have access to the group allocation and will not be informed of which group each participant has been assigned to. In addition, the outcome assessor, who will be responsible for conducting clinical assessments and measuring the study variables, will remain unaware of the participants’ group assignments. Weekly follow-up and assessment of adherence to the intervention will also be conducted by the independent individual to ensure that neither the principal investigator nor the outcome assessor becomes aware of the participants’ group assignments throughout the study. The group allocation codes will be kept by the independent individual until completion of the outcome assessments and will be decoded, if necessary, after the final assessments have been completed. Accordingly, participants and the intervention provider will be aware of the intervention they receive, whereas the principal investigator and outcome assessor will remain blinded to the participants’ group assignments. 2 Rheumatoid arthritis (RA). Intervention group: Participants will receive 30 g of chia seeds daily for 8 weeks. The chia seeds will be fully soaked until gel formation and consumed with yogurt, salad, or smoothie 30 minutes before the main meal. Participants will continue their usual diet throughout the study.. Yes - There is a plan to make this available What will be shared: Only a portion of the data, such as information related to the primary outcome, can be shared. When: One year after publication of the results. To whom: Researchers from academic, scientific, and research institutions, subject to approval by the researcher and compliance with data confidentiality requirements. Conditions: Maintaining data confidentiality, using the data solely for scientific and research purposes, and not transferring the data to third parties. Where to obtain: Applicants may submit their requests to the researcher of the study. Requests will be processed upon approval by the researcher and in accordance with the relevant regulations. How to obtain: Upon receipt of the applicant’s request and approval by the researcher, the de-identified data or documents will be provided to the applicant within a maximum of 30 days. Comments:
public Dr.saeid Ghavamzadeh
West Azerbaijan Province, Urmia, Bahonar Street, Apadana Intersection, Zaker Street, Enghelab Park
Urmia Iran (Islamic Republic of) 5716861111 +98 41 3332 2901 ghavamzadeh@hotmail.com Oroumia University of Medical Sciences scientific Dr.Saeid Ghavamzadeh
West Azerbaijan Province, Urmia, Bahonar Street, Apadana Intersection, Zaker Street, Boostan Enghelab
Urmia Iran (Islamic Republic of) 5716861111 +98 41 3332 2901 ghavamzadeh@hotmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Willingness and informed consent to participate in the study Confirmed diagnosis of rheumatoid arthritis based on established clinical criteria Disease duration of at least 6 months Age between 18 and 70 years Ability to communicate and cooperate throughout the study period 18 years 70 years Both M06.9 Rheumatoid arthritis, unspecified Treatment - Other Intervention group: Participants will receive 30 g of chia seeds daily for 8 weeks. The chia seeds will be fully soaked until gel formation and consumed with yogurt, salad, or smoothie 30 minutes before the main meal. Participants will continue their usual diet throughout the study. **ESR:** Change in erythrocyte sedimentation rate (ESR) from baseline to the end of the 8-week intervention, measured in mm/h using the Westergren method and an ESR reader.**CBC:** Change in complete blood count (CBC) indices from baseline to the end of the 8-week intervention, including white blood cell, red blood cell, and platelet counts and related indices, measured using the Sysmex K21N analyzer.**RF:** Change in serum rheumatoid factor (RF) level from baseline to the end of the 8-week intervention, measured using the latex method and BT1500 analyzer.**CRP:** Change in serum C-reactive protein (CRP) level from baseline to the end of the 8-week intervention, measured using the latex agglutination method and BT1500 analyzer.**Anti-CCP:** Change in serum anti-cyclic citrullinated peptide antibody (Anti-CCP) level from baseline to the end of the 8-week intervention, measured by ELISA and expressed in IU/mL.**Pain:** Change in joint pain severity from baseline to the end of the 8-week intervention, assessed using the Visual Analog Scale (VAS), scored from 0 to 10.**Disease activity:** Change in disease activity from baseline to the end of the 8-week intervention, assessed using the DAS28 score.**Weight:** Change in body weight from baseline to the end of the 8-week intervention, measured in kilograms using the InBody 770.**BMI:** Change in body mass index (BMI) from baseline to the end of the 8-week intervention, expressed in kg/m², using measurements obtained with the InBody 770. Timepoint: Measurement of erythrocyte sedimentation rate (ESR) at baseline (before the intervention) and at the end of the 8-week intervention. Method of measurement: **Erythrocyte Sedimentation Rate (ESR):** Measured using the Westergren method and an erythrocyte sedimentation rate reader after one hour, expressed in millimeters per hour.**Complete Blood Count (CBC):** Venous blood samples measured using the Sysmex K21N automated hematology analyzer, including white blood cell, red blood cell, and platelet counts and related indices.**Rheumatoid Factor (RF):** Measured using the latex agglutination method and the BT1500 analyzer.**C-Reactive Protein (CRP):** Measured using the latex agglutination method and the BT1500 analyzer.**Anti-Cyclic Citrullinated Peptide Antibody (Anti-CCP):** Serum concentration measured using the enzyme-linked immunosorbent assay (ELISA) method and expressed in international units per milliliter.**Joint Pain Severity:** Measured using the Visual Analogue Scale (VAS), consisting of a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain).**Disease Activity:** Assessed using the Disease Activity Score in 28 joints (DAS28).**Body Weight:** Measured using the InBody 770 body composition analyzer.**Body Mass Index (BMI):** Determined based on weight and height measurements obtained using the InBody 770 body composition analyzer. Self-funded campus student, by the researcher, Fatemeh Moslemi Approved 2025-10-29 Ethics committee of Urmia University of Medical Sciences Roudaki St., Shahid Rezi Alley, Milan Tower, Bell 0 Sari Mazandaran Iran (Islamic Republic of)