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zinc supplementation in ulcerative colitis

The effect of zinc supplementation on clinical symptoms, quality of life and its effect on inflammatory biomarkers and the expression of NF-kB, calprotectin, TLR-4 and TNF-a genes in patients with ulcerative colitis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190710044172N1
Enrollment
60
Registered
2022-11-30
Start date
2022-12-22
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis. Ulcerative colitis, unspecified

Interventions

Intervention 1: Intervention group: Along with their medical drugs, including Mesalazine and Azaram, zinc gluconate oral supplement from Karen pharmaceutical company with 30 mg of zinc elemental and c

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Body mass index 18.5 to 35 Diagnosis of ulcerative colitis according to the patient's symptoms, tests and colonoscopy image and intestinal sample pathology Mild to moderate active form of the disease according to the Mayo questionnaire No change in clinical symptoms during the last week of entering the study Absence of concomitant diseases such as malignant diseases and other inflammatory diseases (cancer, kidney failure, heart failure, liver disorders, Wilson's, rheumatoid arthritis, diabetes, psoriasis, Behcet and other inflammatory and autoimmune diseases) No hospitalization and no medication changes during the last 3 months due to the severity of the disease Not having an acute disease (cold, corona and any other viral-bacterial-fungal disease) No intestinal surgery Not taking zinc supplements in the last 2 months Not taking supplements containing antioxidants - omega 3 - vitamin D - probiotic - vitamin E - vitamin A - multivitamin in the last two months

Exclusion criteria

Exclusion criteria: Use of infliximab, Adalimumab, high dose of corticosteroids (above 40 mg), NSAIDs pregnant and lactating women Taking contraceptives Implementation of special diet such as vegetarian diet, ketogenic diet and gluten-free diet

Design outcomes

Primary

MeasureTime frame
Clinical symptoms. Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: Mayo questionnaire.

Secondary

MeasureTime frame
Quality of life. Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: Inflammatory Bowel Disease Quality of Life Short Questionnaire (IBDQ-9).;Serum zinc level. Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit.;Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit.;C-reactive protein (CRP). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit.;Interleukin 17 (IL-17). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit.;Interleukin 6 (IL-6). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit.;Interleukin 10 (IL-10). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit.;Transforming growth factor beta (TGF-ß). Timepoint: At the beginning (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In blood serum sample using ELISA kit.;Tumor necrosis factor alpha (TNF-a). Timepoint: At the beginning (before the start of the intervention) and at the end of th

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoumeh Khalighi Sikaroudi

Tehran University of Medical Sciences

masoomehkhalighi@gmail.com+98 21 8895 5975

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026