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Effects of vitamin D and magnesium co-supplementation on cognitive function and C-reactive protein level in patients with type 2 diabetes: A double-blind randomized placebo-control trial

Protocol summary

Study aim
Effect of vitamin D and magnesium co-supplementation on cognitive function and C-reactive protein level in patients with type 2 diabetes
Design
A double-blind, randomized, parallel group, placebo-control trial on 64 patients with type 2 diabetes. creating a random sequence is done through block randomization by R software.
Settings and conduct
This study is a randomized, double-blind, placebo-controlled trial. 64 people recruitment from Afzalipour Hospital in Kerman with a history of type 2 diabetes for at least 5 years with age 40-65 years old, randomly assigned to receive either 1000 IU vitamin D and 100 mg magnesium elemental (as magnesium oxide) twice a day for 12 weeks (group 1; n = 32) or placebo (group 2; n = 32) for 12 weeks. Cognition, 25 (OH) Vit D, FBS, HbA1c, CRP, body composition, blood pressure are measured at the study baseline and after 12 weeks of intervention. In this study, the researcher, the patients are blinded.
Participants/Inclusion and exclusion criteria
Diagnosis of diabetes by a specialist, at least 5 years of history of diabetes, HbA1C< 8.5%, Age between 40 to 65 years old, Not receiving CNS-related medications, No change in the types or doses of medications in the last 3 months before the trial
Intervention groups
Intervention group: 32 participates with type 2 diabetes who take 1000 IU vitamin D and 100 mg magnesium elemental (as magnesium oxide) twice a day for 12 weeks. Control group: 32 participates with type 2 diabetes who take placebo containing maltodextrin and looks similar to the original supplements twice a day for 12 weeks.
Main outcome variables
Cognitive function, executive function, verbal memory, attention, information processing speed, CRP level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090901002394N50
Registration date: 2024-08-05, 1403/05/15
Registration timing: prospective

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D and magnesium co-supplementation on cognitive function and C-reactive protein level in patients with type 2 diabetes: A double-blind randomized placebo-control trial
Public title
Effects of vitamin D and magnesium co-supplementation in patients with type 2 diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate and signing informed consent Diagnosis of diabetes by a specialist Stable blood glucose level defined by HbA1C< 8.5% Age 40-65 Patients who are currently under medication therapy At least 5 years history of type 2 diabetes
Exclusion criteria:
Having severe complications of diabetes such as amputation, blindness and dialysis Patients with malabsorption syndromes History of stroke, transient ischemic attack and lacunar infarction Patients with severe depression and anxiety, bipolar and psychosis Loss of consciousness for more than 5 minutes Having dementia, Parkinson's, schizophrenia, Huntington's, AIDS, HIV positive Patients with chronic diseases such as liver failure, thyroid diseases and cancer. Alcohol, smoking and drug use Pregnant and lactating women or women who intend to become pregnant Taking drugs affecting the CNS Any change in the patient's medicine or its dosage during the last 3 months before the trial Regular consumption of higher than RDA doses of magnesium and vitamin D supplements and other supplements during the 2 months prior to the intervention Taking medicine containing magnesium more than 150 mg
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Creating a random sequence is done through block randomization and the size of the blocks is 4. block classification of participants based on age (40 to 54 years and 55 to 65 years) will be done through R software. Concealment of random allocation will be done through the use of sealed opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the purpose of blinding, label A and B will be placed on the supplement box and will remain confidential until the end of the data analysis. Participants, investigator, healthcare providers and outcome assessors will not know the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2024-06-23, 1403/04/03
Ethics committee reference number
IR.IUMS.REC.1403.275

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications

Primary outcomes

1

Description
Cognitive function
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
MoCA (Montreal Cognitive Assessment) test

2

Description
Executive function
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Verbal fluency test

3

Description
Verbal memory
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Auditory Verbal Learning Test

4

Description
Attention
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Stroop Color and Word Test

5

Description
information processing speed
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Stroop Color and Word Test

6

Description
CRP (C-Reactive Protein) level
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Laboratory test

Secondary outcomes

1

Description
FBS
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Laboratory test

2

Description
HbA1c
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Laboratory test

3

Description
25 (OH) Vit D
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
Laboratory test

4

Description
Blood pressure
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
sphyngomanometer

5

Description
Body composition
Timepoint
before intervention and after 12 weeks of intervention
Method of measurement
scale

Intervention groups

1

Description
Intervention group: D3 forte 1000 IU containing 1000 IU vitamin D3 and 100 mg magnesium elemental (as magnesium oxide) produced by Arian Salamat Sina Company twice a day for 12 weeks
Category
Treatment - Other

2

Description
Control group: Placebo containing maltodextrin, avicel, polyvinylpyrrolidone (PVP) and talc and similar to the original supplements. Twice a day for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Dr. Mohammadhossein Gozashti
Street address
Afzalipur Hospital, Imam Khomeini Highway, next to Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
drgozashti@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 5533
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Arabpour
Position
Master student in Clinical nutrotion
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of public health, Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 4805
Email
zahra.arabpour.2077@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of public health, Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 4805
Email
sh_jazayeri@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Arabpour
Position
Master student in clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of public health, Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 4805
Email
zahra.arabpour.2077@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The primary and secondary results of this study will be provided to the requesters
When the data will become available and for how long
Since the publication of the article resulting from this study, it will be possible to make the data available for the next two years.
To whom data/document is available
Known researchers from prestigious academic research centers.
Under which criteria data/document could be used
If the intellectual rights of the providers of this research are preserved and the proposed research is aimed at the goals of the current study or solving the clinical problem of the target group of this study, there is a possibility of cooperation.
From where data/document is obtainable
Direct contact with the email address or phone number of the responsible author or the administrators of this research project.
What processes are involved for a request to access data/document
After the contact of the researchers, the process of accessing the data and conducting joint research with the requesters will be done for a maximum of one month.
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