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"zinc supplementation"; "Ulcerative colitis"

zinc supplementation in patients with ulcerative colitis: effects on clinical symptoms, and inflammatory/anti-inflammatory cytokines affecting the immune system

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190712044182N3
Enrollment
50
Registered
2022-09-18
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

ulcerative colitis disease. Ulcerative colitis, unspecified

Interventions

Intervention 1: Intervention group: Patients take one daily zinc gluconate softgel from Dana Pharmaceutical Company with 40 mg of elemental zinc and capsule filler (glycerol, gelatin, and lecithin) al

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Body mass index between 18.5 and 35 ?Diagnosis of ulcerative colitis according to the patient's symptoms, tests and colonoscopy, and intestinal sample pathology Mild to moderate active form of the disease according to the Mayo questionnaire Absence of concomitant diseases not taking supplements containing zinc during the last 2 months No use of infliximab, Sinora, high dose of corticosteroids (above 40 mg), NSAIDs Not pregnant or lactating Not taking contraceptives

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of clinical symptoms. Timepoint: At the baseline (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
Serum level of Interlukin-6. Timepoint: At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In serum sample using ELISA kit.;Serum level of Interlukin-17. Timepoint: At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In serum sample using ELISA kit.;Serum level of TNF-a. Timepoint: At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In serum sample using ELISA kit.;Quality of life. Timepoint: At the baseline (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 level of Interlukin-10. Timepoint: At the baseline (before the start of the intervention) and at the end of the intervention (60 days after taking zinc or placebo). Method of measurement: In serum sample using ELISA kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Masoodi

Iran University of Medical Sciences

masoodi47@yahoo.com+98 21 86701

Outcome results

None listed

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