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.
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.
Design
A double blinded randomized controlled clinical trial with parallel groups
Settings and conduct
This study will be a randomized, double-blind clinical trial in type 2 diabetes patients in Emam Reza hospital in Tabriz. Participants will be recruited through a convenience sampling and randomly divided into two groups matched based on body mass index, age. Similar envelopes will be used to conceal the allocation in opaque numbered packages.
Participants/Inclusion and exclusion 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: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
Intervention groups
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.
Control group: flaxseed oil soft gel placebo three times a day and a vitamin D3 placebo once weekly for 8 weeks
Main outcome variables
Serum concentration of inflammatory indices (hs-CRP), Serum concentration of oxidative stress indices (MDA and TAC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161022030424N8
Registration date:2023-09-12, 1402/06/21
Registration timing:prospective
Last update:2023-09-12, 1402/06/21
Update count:0
Registration date
2023-09-12, 1402/06/21
Registrant information
Name
Neda Dolatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
dolatkhahn@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
vitamin D3 and flaxseed oil supplementation effects in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS) with block sizes of 2and 4. Similarly sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention and placebo supplements will be prepared in exactly the same way in terms of shape, color, and odor, and will be placed in a small envelope containing 8 and 168 tablets for each participant for 8 weeks consumption. The envelopes will be opened in the order in which the participants enter this stage from number 1, and an envelope containing the supplement will be provided to the participant for 8 weeks. Outcome assessors, the person responsible for statistical analysis of the data, and the respondents will be blinded to the type of supplement received until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.TBZMED.REC.1402.210
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
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
2
Description
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 outcomes
1
Description
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
2
Description
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
3
Description
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
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
Control group: flaxseed oil soft gel placebo three times a day and a vitamin D3 placebo once weekly for 8 weeks