Condition 1: Anemia. Condition 2: Nutritional Status. Condition 3: Depression. Condition 4: Hemodialysis. Anaemia in other chronic diseases classified elsewhere Protein-energy malnutrition of moderate and mild degree Depressive episode Extracorporeal dialysis
Conditions
Interventions
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 f
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
Sponsors
Tehran University of Medical Sciences
Zahravi Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 turbidimet | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed