]>
IRCT201202203043N5 IRCT 2012-04-10 Tehran University of Medical Sciences Evaluating therapeutic effects of omega-3 fatty acids on anemia and nutritional status in hemodialysis patients with depression Evaluating therapeutic effects of omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid) on anemia and nutritional status in hemodialysis patients with depression 2012-05-04 anticipated 50 Complete https://irct.ir/trial/3051 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Anemia. Condition 2: Nutritional Status. Condition 3: Depression. Condition 4: Hemodialysis. Intervention 1: Intervention Group: Omega-3, 300 mg oral capsule, 2 capsules three times daily for 4 months. Intervention 2: Control Group: Placebo, 300 mg oral capsule, 2 capsules three times daily for 4 months.
public
scientific Dr. Mohammad Reza Khatami
Nephrology Research Center, Hemodialysis ward, Imam Khomeini Hospital, Doctor Gharib Street, The end of Keshavarz Boulevard, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2679 khatamis@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age more than 16 years old; Thrice weekly hemodialysis from the last three months (at least); The patient's ability to understand and sign the consent form; Use of biocompatible hemodialysis membrane; Proper functioning of arteriovenus fistula or indwelling catheter; Beck depression score equal to or more than 16; Post-dialysis body mass index between 20 and 30 Exclusion Criteria: Pregnancy; Active, uncontrolled or severe chronic inflammatory disease (autoimmune diseases, active connective tissue diseases, malignancy, AIDS, hepatic and pulmonary diseases); Chronic infection or acute infection in a recent month; Life expectancy of less than 4 months; Asthma or Chronic obstructive pulmonary disease; Other concurrent Psychiatric disorders; Hypothyroidism; Hemoglubinopathies and other causes of anemia (other than iron deficiency); Simultaneous participation in other trials (Drug or Supplemental); History of medical (like MI or Strock) or surgical illness in the last three months; Malabsorption syndrome; Bleeding disorders (including coagulopathy) or high risk for bleeding; Diet change in a recent month; Consumption of omega-3 supplements in the past 3 months; Intolerance or allergy to fish oil; Use of drugs effective on inflammatory factors (like corticosteroides or other immunosuppressives, Non-steroidal antiinflammatory drugs, contraceptives, Pentoxifylline) in the past 6 weeks; Concurrent use of antidepressants, antipsychotics, antiepileptics (other than gabapentin), methyldopa, cimetidine and serotonergic agents (like triptans, tramadol, tryptophan and linezolid); Warfarin therapy ; Alcohol abuse and other materials that cause dependency 16 years no limit Both D63.8* E44 F32 Z49.1 Anaemia in other chronic diseases classified elsewhere Protein-energy malnutrition of moderate and mild degree Depressive episode Extracorporeal dialysis Treatment - Drugs Placebo Intervention Group: Omega-3, 300 mg oral capsule, 2 capsules three times daily for 4 months Control Group: Placebo, 300 mg oral capsule, 2 capsules three times daily for 4 months Serum Albumin Level. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: colorimetric method particularly the bromcresol green (BCG) assay. Serum pre-albumin Level. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: Eliza Kit. Serum Transferrin Level. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: Immunoturbidimetric assay. Body Mass Index (BMI). Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: Weight (Kg) divided by Height (m) square. Mid-arm circumference. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: By measuring tape. Hemoglobin level. Timepoint: Immediately before starting the intervention, monthly and after intervention. Method of measurement: cyanmethemoglobin method (colorimeter, spectrophotometer). Interleukin- 6. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: Eliza Kit. Serum Hepcidin level. Timepoint: Immediately before starting the intervention, three months after the intervention and after the completion of intervention. Method of measurement: Eliza Kit. Required dose of iron in hemodialysis patients with depression. Timepoint: Immediately before starting the intervention and immediately after intervention. Method of measurement: Study of patient records and interview with the patient. Required dose of erythropoietin in hemodialysis patients with depression. Timepoint: Immediately before starting the intervention and immediately after intervention. Method of measurement: Study of patient records and interview with the patient. Serum Ferritin Level. Timepoint: Immediately before starting the intervention, three months after the intervention and after the completion of intervention. Method of measurement: antigen/latex-antibody reaction by the end-point method. Serum Iron level. Timepoint: Immediately before starting the intervention, three months after the intervention and after the completion of intervention. Method of measurement: colorimetric method. Transferrin saturation. Timepoint: Immediately before starting the intervention, three months after the intervention and after the completion of intervention. Method of measurement: Product ratio of serum iron to total iron binding capacity in 100. Tumor Necrosis Factor-a. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: Eliza Kit. Interleukin- 10. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: Eliza Kit. C-reactive protein. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: latex-enhanced turbidimetric immunoassay method. Depression. Timepoint: Immediately before starting the intervention and immediately after intervention completion. Method of measurement: Beck Depression Inventory. Zahravi Pharmaceutical Company Tehran University of Medical Sciences Zahravi Pharmaceutical Company Approved 2012-02-27 Research deputy of Tehran University of Medical Sciences 4th Floor, Central Organization of Tehran University of Medical Sciences, Qods Avenue, Keshavarz Boulevard Steet, Tehran, Iran Tehran Iran (Islamic Republic of)