Effect of vitamin A supplementation on immune system indices in patients with ulcerative colitis

Phase 2

• Conditions: Condition 1: Ulcerative colitis. Condition 2: Ulcerative colitis. Condition 3: Ulcerative colitis. Condition 4: Ulcerative colitis.; Ulcerative (chronic) ileocolitis; Ulcerative (chronic) enterocolitis; Ulcerative (chronic) proctitis; Ulcerative (chronic) rectosigmoiditis

• Registration Number: IRCT201008184105N3
• Lead Sponsor: Deputy of Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

presence of ulcerative colitis, age range 20 to 45 years, signing consent, receiving similar medications during 6 months prior to the intervention, (a Salazyny drugs: Azathioprine, sulfasalazine)
Exclusion criteria: Presence of any autoimmune disease (disease, MS, lupus erythematosus), chronic exposure to any infectious disease, inflammation, diabetes or cancer, consumption of any food supplement such as multivitamin- mineral, vitamin A, zinc and vitamin D and omega-3), use any type of anti-inflammatory drugs such as NSAIDS and immunosuppressives (cyclosporine and ...), pregnancy or intention to become pregnant, any surgery during six months prior to the study, BMI more than 30

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CD4 lymphocyte count. Timepoint: before & after (day 0 & 45). Method of measurement: flowcytometery.;Proinflammatory cytokine (IL12). Timepoint: before & after (day 0 & 45). Method of measurement: ELISA.;Acute phase protein(hs-CRP). Timepoint: before & after (day 0 & 45). Method of measurement: turbidometeric.;Anti inflammatory cytokine(IL10 & IL4). Timepoint: before & after (day 0 & 45). Method of measurement: ELISA.;Serum retinol. Timepoint: before & after (day 0 & 45). Method of measurement: HPLC.

Secondary Outcome Measures

Name	Time	Method
Clinical symotoms. Timepoint: before & after (day 0 & 45). Method of measurement: trouvel witt index.;Food intake habits & dietary intake. Timepoint: before & after (day 0 & 45). Method of measurement: FFQ & dietary record (3 days).