Diarrhea
Conditions
Interventions
This is a multicenter, triple-blind, parallel, randomized clinical trial that will evaluate folic acid supplementation and the occurrence of diarrhea in patients with type II diabetes mellitus who wil
Sponsors
Universidade Federal de São João del-Rei
Universidade Federal de São João del-Rei
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Male and female patients will be recruited. Age over 18 years. Patients using 500 mg immediate-release metformin hydrochloride for the first time
Exclusion criteria
Exclusion criteria: Pregnant women. Patients with a history of or declared allergies to folic acid. Those considered incapable of completing the adverse event perception form accurately: for the latter exclusion criterion, the patient's level of education and the presence or absence of a caregiver will be considered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe a reduction in diarrhea related to the use of immediate-release metformin hydrochloride 500 mg in the group receiving folic acid supplementation (intervention), assessed through the adverse event perception form over the 30 days following the initiation of the medicine | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe a reduction in abdominal discomfort related to the use of immediate-release metformin hydrochloride 500 mg in the group receiving folic acid supplementation (intervention), assessed through the adverse event perception form over the 30 days following the initiation of the medicine;It is expected to observe a lower impact of gastrointestinal adverse events on daily activities, energy levels, mood, family life, and social interactions related to the use of immediate-release metformin hydrochloride 500 mg in the group receiving folic acid supplementation (intervention), assessed through the adverse event perception form over the 30 days following the initiation of the medicine | — |
Countries
Brazil
Contacts
Public ContactAngelo Meri Junior
Universidade Federal de São João del-Rei
Outcome results
None listed