sickle cell anemia
Conditions
Interventions
It is a randomized double-blind placebo-controlled clinical study with adult patients of both sexes, with molecular diagnosis of SCA, in continuous use of HU, at doses from 500mg to 2000mg mg / day, i
Other
G07.203.300.456
Sponsors
Universidade Federal do Ceará
Universidade Federal do Ceará
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients volunteers between 18 and 80 years with sickle cell anemia; both genders; in use of hydroxiurea from 500mg per day; baseline
Exclusion criteria
Exclusion criteria: Patients who do not have sickle cell anemia; Patients who refuse to participate in the study not signing the ethic term; those who have had transfusional therapy in the last three months; patients using iron chelator and antioxidant vitamins; patients smokers and drinkers; pregnant or with diabetes mellitus or with some picture of renal or hepatic insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased nitrite levels in the 4-month clinical trial using the ELISA kit for the amount of plasma nitrite in the patient's plasma in grams per liter;There was a significant increase analyzed by p value of 0.004 after 4 months treatment There was a significant increase analyzed by the p-value of 0.004 after the 4-month treatment mentioned above The nitrite levels before treatment were 38.27 g per L, standard deviation of 17.27, to 34.45 g per L, standard deviation of 11.25 after four months of treatment The study group obtained nitrite levels before starting treatment of 36.55 g per L, with a standard deviation of 20.23 to 48.64, with a standard deviation of 20.63 after four months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of pain frequency during treatment, from pain once a day to once a week, analyzed through each patient's questionnaire;The patients in the study group reduced that pain frequency with p of 0.027 after 4 months treatment | — |
Countries
Brazil
Contacts
Public ContactRenata Eleuterio
Universidade Federal do Ceará
Outcome results
None listed