Clinical, anti-inflammatory and antioxidant effects of fish oil and vitamin D supplementation in sickle cell disease patients: a randomized, blinded, placebo-controlled study
Phase 2
- Conditions
- Sickle cell disease
- Registration Number
- RBR-10r7d6f3
- Lead Sponsor
- niversidade do Estado do Rio de Janeiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Adults with ages ranging from 19 to 59 years of age; Be homozygous for sickle cell anemia - HbS (SS genotype); Possibility of attendance at periodic laboratory visits and examinations; Be lucid and oriented.
Exclusion Criteria
Participants who have had blood transfusions in the last 1 month before the first evaluation; Participants who present an episode of disease exacerbation at the time of the first evaluation; Participants who have taken vitamin D and / or omega-3 supplementation for less than 6 months or at the time of the first evaluation; Have not been hospitalized for less than fifteen days; People with other types of hemoglobinopathies; Use of Hydroxyurea; Pregnant women.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of the clinical and inflammatory condition.<br>For this, the following parameters will be used: reduction in the number of hospitalizations, reduction in the frequency of pain episodes, reduction in pain intensity, blood count evaluation, lipid profile, C-reactive protein, lactate dehydrogenase, tumor necrosis factor alpha (TNF- a), VCAM, P-selectin, HbS and HbF concentration, indirect oximetry.
- Secondary Outcome Measures
Name Time Method evaluation of vitamin D levels in patients with sickle cell anemia.<br>Those that are sufficient or deficient according to the measurement of 25 (OH) D will be evaluated, using high performance liquid chromatography coupled with a dioderray detector (HPLC-DAD).;reduction of vaso-occlusive pain crises, through reporting and / or consulting the medical record of the number of hospitalizations before and after supplementation.;improvement of the disposition, through the report of daily activities and tiredness (fatigue) or improvement of the disposition when performing them, before and after the supplementation.;improvement of the hemolytic and vaso-occlusive condition, with evaluation of lactate dehydrogenase and haptoglobin.