Clinical, anti-inflammatory and antioxidant effects of fish oil and vitamin D supplementation in sickle cell disease patients: a randomized, blinded, placebo-controlled study

INTERVENTION: C15.378.071.141 G07.203.300.456 Total sample of 120 individuals, matched for gender and age group. Participants will be divided into four groups: Control (30 participants with sickle cell anemia who will receive both vitamin D and fish oil placebos); OD group (30 participants with sickle cell anemia, who will receive fish oil and vitamin D supplementation); group O‐ (30 participants with sickle cell anemia who will receive fish oil supplementation and vitamin D placebo); group D‐ (30 participants with sickle cell anemia who will receive vitamin D supplementation and fish oil placebo). Supplementation of fish oil will be performed in the amount of 1000 mg per gelatin capsule, having in its composition the minimum amount of 330 mg of Eicosapentanoic acid (EPA), 220 mg of Docosahexanoic acid (DHA) and 1 mg of vitamin E. of omega‐3 fatty acids must be fish oil and will be free of heavy metals and flavoring. The placebo will have the same presentation, consisting of the same material and the same color of the supplement, containing water inside and 1 mg of vitamin E. The recommended daily dose will be 4 capsules / day, 2 capsules in the morning and 2 capsules / night. In relation to vitamin D (cholecalciferol), its supplementation will be performed with 1000 IU / drop, without flavor, having as vehicle the medium chain triglyceride. The recommended daily dose will be 4 drops / day, 2 drops in the morning and 2 drops / night. As a placebo for vitamin D, distilled water will be offered. The amount given in one day does not exceed the recommended limit dose for adults (IOM‐2011) and is therefore considered safe for the individual. CONDITION: Sickle cell disease PRIMARY OUTCOME: Improvement of the clinical and inflammatory condition.; 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: evaluation of vitamin D levels in patients with sickle cell anemia. ; 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). 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. reduction of vaso‐occlusive pain crises, through reporting and / or consulting the medical record of the number of hospitalizations before and after supplementation. 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.