omega 3 and metabolic syndrome

Effect of omega-3 fatty acids on the components of metabolic syndrome in schizophrenic, bipolar and schizoaffective patients taking olanzapine plus sodium valproate or olanzapine plus lithium.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138712231764N1

Enrollment

Registered

2009-05-26

Start date

2008-06-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia, bipolar mood disorder, schizoaffective. Schizophrenia ,Schizoaffective disorders ,Bipolar affective disorder

Interventions

Intervention 1: Intervention: omega 3 capsules 1000 mg ( containing 300 mg EPA/DHA). 1 capsule/day in the first intervention week, 2 capsules/day (divided) in the second intervention week and 3 capsu

Prevention

Intervention: omega 3 capsules 1000 mg ( containing 300 mg EPA/DHA). 1 capsule/day in the first intervention week, 2 capsules/day (divided) in the second intervention week and 3 capsules/day (divided

Control: placebo, 1 capsule/day in the first intervention week, 2 capsules/day (divided) in the second intervention week and 3 capsules/day (divided) from the third intervention week till the end of i

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: psychiatric patients taking olanzapine plus sodium valproate or olanzapine plus lithium with clinical diagnosis of schizophrenia, bipolar mood disorder, schizoaffective disorder, ages between 18-60 yrs. Exclusion criteria: 1- Previous treatment with study drugs (olanzapine, sodium valproate, lithium) during the three months prior to trial initiation/participation, 2- Having a significant active medical problem or abnormal lab tests before initiation of trial including: Liver function tests= 3 normal , Thyroid stimulating hormone > 4.2 m.I.U/L, GFR 125 mg/dl, TG = 500 mg/dl , TG between 200-500 and Non-HDL cholesterol greater than or equal to 30+ target LDL: in cases of TG between 200-500, first Non-HDL cholesterol is calculated. Then the goal LDL of the patient is assessed according to NCEP ATP III LDL goals. Participants with TG between 200-500 are excluded if their Non-HDL cholesterol is greater than or equal to 30 + target LDL. 3- Pregnancy and lactation 4-Recent (within 4 weeks) consumption of omega 3 fatty acids 5-BMI = 30 6-Contraindications for the study drugs 7-Patients or their family refusal to participation 8-Taking Drugs much affecting study parameters.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: at the beginning of the study and 6 weeks after intervention. Method of measurement: digital scale.;Height. Timepoint: at the beginning of the study. Method of measurement: standard methods.;BMI. Timepoint: at the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated as body weight (kg) divided by the height in meters squared.;Waist circumference. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: measuring tape.;Blood pressure. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Mercury sphygmomanometer.;FBS. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure.;High-density lipoprotein (HDL). Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure.;TG. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure.	—

Measure

Time frame

Weight. Timepoint: at the beginning of the study and 6 weeks after intervention. Method of measurement: digital scale.;Height. Timepoint: at the beginning of the study. Method of measurement: standard methods.;BMI. Timepoint: at the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated as body weight (kg) divided by the height in meters squared.;Waist circumference. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: measuring tape.;Blood pressure. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Mercury sphygmomanometer.;FBS. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure.;High-density lipoprotein (HDL). Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure.;TG. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic procedure.

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Secondary

Measure	Time frame
Total cholesterol. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic assays.;LDL. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic assays (Directly measured).;VLDL. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated using the formula: TC (total cholesterol)- (HDL+ LDL).;Non-HDL cholesterol. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated by the formula: Total cholesterol- HDL-c.;Fasting Insulin. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Chemiluminescence.;Hgb A1C. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry.;HOMA-IR. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated.;Lipoprotein (a). Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry.;Fibrinogen. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Clauss Coagulation method.;CRP-hs. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry.	—

Measure

Time frame

Total cholesterol. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic assays.;LDL. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Enzymatic assays (Directly measured).;VLDL. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated using the formula: TC (total cholesterol)- (HDL+ LDL).;Non-HDL cholesterol. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated by the formula: Total cholesterol- HDL-c.;Fasting Insulin. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Chemiluminescence.;Hgb A1C. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry.;HOMA-IR. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Calculated.;Lipoprotein (a). Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry.;Fibrinogen. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Clauss Coagulation method.;CRP-hs. Timepoint: At the beginning of the study and 6 weeks after intervention. Method of measurement: Immunoturbidimetry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. T. Faghihi

Tehran University of Medical Sciences

tfaghihi@razi.tums.ac.ir+98 21 6695 4709

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 25, 2026