Effect of combined omega-3 and vitamin D supplementation in treatment of coronary heart disease

Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in type 2 diabetic patients with coronary heart disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017090133941N15

Enrollment

Registered

2017-11-01

Start date

2017-11-01

Completion date

Unknown

Last updated

2020-08-17

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

Conditions

Coronary Heart Disease. Chronic ischaemic heart disease, unspecified

Interventions

Intervention 1: Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 24 weeks orally. Intervention 2: Control group

Eligibility

Sex/Gender

All

Age

45 Years to 85 Years

Inclusion criteria

Inclusion criteria: Subjects aged 45-85 years Diagnosed with type 2 diabetes and coronary heart disease Vitamin D-deficient

Exclusion criteria

Exclusion criteria: Consuming vitamin D supplements and omega-3 fatty acids within the last 3 months Experiencing an acute myocardial infarction or cardiac surgery within the past 3 months Renal or hepatic disorder

Design outcomes

Primary

Measure	Time frame
Mean left CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography.;Maximum left CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography.;Mean right CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography.;Maximum right CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography.	—

Measure

Time frame

Mean left CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography.;Maximum left CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography.;Mean right CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography.;Maximum right CIMT. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Sonography.

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Secondary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Total cholesterol. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Total cholesterol. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 24 weeks of intervention. Method of measurement: Spectrophotometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026