Comparative effectiveness of adding Omega-3 or Vitamin D to standard therapy in preventing and treating episodes of painful crisis in pediatric sickle cell patients.
Summary: The purpose of the study was to examine the comparative effectiveness of supplementation of omega-3 or vitamin D to standard therapy with hydroxyurea and ibuprofen used for prevention and treatment of pain crises in pediatric patients with sickle cell disease.
Conclusion: Results showed that omega-3 was more effective than vitamin D or standard treatment alone relative to pain crises and most of the other studied items. Vitamin-D was more effective than standard therapy alone.
Objective: Sickle Cell Anemia (SCA), also called the Sickle Cell Disease (SCD), is an inherited hematological disorder characterized by a syndrome of acute anemia and a painful crisis. The sickling hemoglobin, Hgb-S causes viscosity and inflammation of blood vessels. Eventually, the red blood cells get eliminated from the circulation process, which leads to hemolytic anemia. This study examined the comparative effectiveness of supplementation of Omega-3 or vitamin-D to standard therapy (hydroxyurea + Ibuprofen) used for prevention and treatment of pain crises in pediatric patients living with SCD. Patients and
Methods: 165 patients participated in this randomized, double-blind, standard therapy-controlled, parallel-design trial. The patients were randomly divided into three groups, receiving three capsules of either 1,000 mg Omega-3 fish oil (400 mg EPA and 300 mg DHA) or 1.5 mL vitamin-D (2,800 IU/7 ml) daily for 10 months plus the standard therapy. Lactate dehydrogenase, high-density lipoprotein (HDL), low-density lipoprotein (LDL), hematocrit, reticulocyte count, and white-blood-cell count were determined at baseline (month zero) and end of the 10th month. The pain severity was measured using the visual analog scale method (VAS). Therefore, a 10-cm ruler with a VAS design was used to determine the patient pain intensity. The baseline time point was defined as the time spot before starting to deliver the experimental medication to the patients (month zero). At that time, the biodata of the patient on the frequency of pain episodes and the rest of the variables were collected, and the baseline data were one-year retrospective data.
Results: Of 165 patients enrolled in the trial, 150 were included in the final analysis. At the end of the study, there was a significant increase in serum LDL and HDL in the Omega-3 group as compared with the control group (mean of 82 mg/dL vs. 57 mg/dL; p < 0.01 and mean of 47 mg/dL vs. 43 mg/dL; p < 0.028, respectively). Other laboratory parameters were significantly influenced. The number of painful crises and pain levels was significantly decreased in the Omega-3 group compared with the control group (mean of one-episode vs. mean of three episodes; p = 0.01, mean of three on pain scale vs. six on pain scale; p = 0.018).
Conclusions: Results showed that Omega-3 was more effective than vitamin-D or standard treatment alone relative to pain crises and most of the other studied items. Vitamin-D was more effective than standard therapy alone. Clinicians should consider the addition of Omega-3 supplements to the standard therapy and a de-escalation dose plan for the hydroxyurea medication.