vitamin D3 and flaxseed oil supplementation effects in type 2 diabetes

Phase 3

Recruiting

• Conditions: Type 2 diabetes mellitus.; Type 2 diabetes mellitus

• Registration Number: IRCT20161022030424N8
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 104

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.