Crohn Disease
Conditions
Interventions
This is a non-randomized, two-arm, single-blind clinical study. Experimental group: initially composed of 23 patients at time zero (T0), all with serum zinc concentrations below the recommended value
D01.552.544.940
Sponsors
Fundação de Amparo à Pesquisa do Estado do Piauí - FAPEPI
Universidade Federal do Piauí
Eligibility
Age
20 Years to 59 Years
Inclusion criteria
Inclusion criteria: Both sexes. Aged between 20 and 59. Clinical diagnosis of ulcerative colitis. Non-smokers. No comorbidities such as diabetes, hypertension, kidney failure, cardiovascular disease, rheumatic diseases or other diseases with inflammatory processes. Not using a vitamin-mineral supplement that interferes with zinc metabolism. Not be currently using monoclonal antibody therapy. Participants linked to the Association of Crohn's Disease Patients of the North and Northeast of Brazil (ACROHNN). Follow-up at the University Hospital of the Federal University of Piauí (HU-UFPI)
Exclusion criteria
Exclusion criteria: Start of monoclonal antibody therapy during the study. Change of city or state. Lack of telephone contact. Inability to continue using the supplement. Absence from biological material collection. Age group outside the 20-59 age range. No relationship with ACROHNN. No follow-up by HU-UFPI. Diagnosis of an intestinal disease other than Ulcerative Retocolitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The increase in serum zinc concentrations was assessed using laboratory tests carried out at T0 (start), T1 (30 days) and T2 (60 days). The parameter used was plasma zinc concentration (µg/dL), determined by atomic absorption spectrometry. The main outcome considered was the normalization or elevation of serum levels to values equal to or greater than 70 µg/dL at the end of the intervention (T2) | — |
Secondary
| Measure | Time frame |
|---|---|
| The gene expression of the Metallothionein-1 (MT-1) protein was assessed as a secondary endpoint by means of RT-qPCR in peripheral blood samples collected at T0 and T2. This endpoint aimed to investigate the possible effects of zinc supplementation on regulating the expression of this protein involved in mineral metabolism | — |
Countries
Brazil
Contacts
Public ContactVitória Mendes
Universidade Federal do Piauí - UFPI
Outcome results
None listed