vitamin D3 and flaxseed oil supplementation effects in type 2 diabetes

Investigation of the effect of high-dose vitamin D3 with alpha linoleic acid (flaxseed oil) supplementation on serum indices of inflammation and oxidative stress in the elderly with type 2 diabetes.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20161022030424N8

Enrollment

104

Registered

2023-09-12

Start date

2023-09-23

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Type 2 diabetes mellitus. Type 2 diabetes mellitus

Interventions

Intervention 1: Intervention group: vitamin D3 supplements at 50,000 IU per week and 1000 mg of flaxseed oil soft gel(made by Barij esans company) three times a day for 8 weeks. Intervention 2: Contro

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: the age of 65 and above the patient has been diagnosed with type 2 diabetes based on medical records hemoglobin A1C level is between 10-5/6 anti-diabetic treatment, which has not been changed for at least 8 weeks 25-hydroxy vitamin D3 level between 125-30 nano moles per liter

Exclusion criteria

Exclusion criteria: Type 1 diabetes Smoking and alcohol consumption Severe uncontrolled diabetes Severe uncontrolled blood pressure Lack of interest in continuing the study Unusual stress event during the study 25-hydroxy vitamin D3 level less than 30 and higher than 125 nano moles per liter

Design outcomes

Primary

Measure	Time frame
Serum concentration of inflammatory indices (hs-CRP). Timepoint: Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Biochemical analysis.;Serum concentration of oxidative stress indices (MDA and TAC). Timepoint: Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Biochemical analysis.	—

Measure

Time frame

Serum concentration of inflammatory indices (hs-CRP). Timepoint: Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Biochemical analysis.;Serum concentration of oxidative stress indices (MDA and TAC). Timepoint: Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Biochemical analysis.

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Secondary

Measure	Time frame
Anthropometric indices. Timepoint: Measurement of the anthropometric indices at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Seca digital scale.;Quality of life. Timepoint: Evaluation of the quality of life at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: SF-36 quality of life questionnaire.;Metabolic indices(triglycerides, LDL cholesterol). Timepoint: Measurement of Metabolic indices(triglycerides, LDL cholesterol) at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Biochemical analysis.	—

Measure

Time frame

Anthropometric indices. Timepoint: Measurement of the anthropometric indices at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Seca digital scale.;Quality of life. Timepoint: Evaluation of the quality of life at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: SF-36 quality of life questionnaire.;Metabolic indices(triglycerides, LDL cholesterol). Timepoint: Measurement of Metabolic indices(triglycerides, LDL cholesterol) at baseline (before intervention) and 8 weeks after vitamin D3 with alpha - linoleic acid (flaxseed oil) supplementation. Method of measurement: Biochemical analysis.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Dolatkhah

Tabriz University of Medical Sciences

dolatkhahn@tbzmed.ac.ir+98 41 3336 1928

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jul 31, 2026