The aim of this study is to determine the effects of magnesium and zinc co-supplementation on metabolic profiles; inflammatory factor and biomarkers of oxidative stress in patients with coronary heart disease and type 2 diabetes mellitus .
Design
randomized double blind , controlled with placebo and drug , parallel clinical trial on 60 patients.randomization will be done based on Stratified randomization using statistical software.
Settings and conduct
Patients with coronary artery disease and type 2 diabetes have been evaluated for inclusion criteria in the heart clinic of Kashan University of Medical Sciences affiliated to the University of Medical Sciences. Anthropometric indices; nutritional variables; metabolic profiles; inflammatory factors; and oxidative stress biomarkers are measured at the beginning of the study and after intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: patients with coronary disease on angiography ;patients with diabetes with American Diabetes Association; age 95-40 years and Exclusion Criteria: thyroid disease;No change in levels of LDL patients six weeks after the intervention; Acute myocardial infarction in the last 3 months; Cardiac surgery in the last 3 months; Significant kidney and liver failure; Unwillingness to cooperate; Antibiotic use during study.
Intervention groups
People at the beginning of the study will be placed in one of the two groups receiving supplementation of magnesium and zinc and the placebo group (containing starch) once a day for 3 months.
Main outcome variables
The primary outcome is insulin resistance and the secondary consequences of changes in the metabolic profile; inflammatory factors and oxidative stress biomarkers.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012438N31
Registration date:2019-05-11, 1398/02/21
Registration timing:retrospective
Last update:2019-05-11, 1398/02/21
Update count:1
Registration date
2019-05-11, 1398/02/21
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium and zinc co-supplementation on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus
Public title
The effect of magnesium and zinc co-supplementation in patients with coronary heart disease and type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with coronary disease on angiography ;patients with diabetes with American Diabetes Association; age 40 to 95 years;No smoking
Exclusion criteria:
thyroid disease;No change in levels of LDL patients six weeks after the intervention;Infection; Consumption of any type of supplement (vitamin, mineral, etc.) by the patient in the last 3 months; Acute myocardial infarction in the last 3 months; Cardiac surgery in the last 3 months; Significant kidney failure; Significant liver failure; Unwillingness to cooperate; Antibiotic use during study
Age
From 40 years old to 95 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is that the patients are placed on separate classes according to two criteria: BMI (BMI <25 BMI≥25) and age (<65 and 65≤), and then randomly in one of two groups receiving magnesium and zinc supplements and the placebo group (containing starch) are included. The study is done using the Stat Trek software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebo after coding by the researcher are placed under supervision of clinical caregiver and then clinical caregiver provided them to the participants. Both clinical caregiver and participants are kept blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-12-10, 1397/09/19
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.079
Health conditions studied
1
Description of health condition studied
coronary heart disease and type 2 diabetes mellitus
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
HOMA-Index
Timepoint
Baseline and End-of-trial
Method of measurement
Formula calculation
Secondary outcomes
1
Description
Fasting plasma glucose
Timepoint
Fasting plasma glucose
Method of measurement
Enzymatic
2
Description
Insulin
Timepoint
Baseline and End-of-tria
Method of measurement
Elisa
3
Description
QUICKI
Timepoint
Baseline and End-of-tria
Method of measurement
Formula calculation
4
Description
HbA1c
Timepoint
Baseline and End-of-tria
Method of measurement
Laboratory clinical kit
5
Description
Nitric oxide (NO)
Timepoint
Baseline and End-of-tria
Method of measurement
Spectrophotometry
6
Description
High sensitivity C-reactive protein (hs-CRP)
Timepoint
Baseline and End-of-tria
Method of measurement
Elisa
7
Description
Total Antioxidant Capacity (TAC)
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
8
Description
Total glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
9
Description
Malondialdehyde(MDA)
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
10
Description
Serum Total cholestrol
Timepoint
Baseline and End-of-trial
Method of measurement
Laboratory clinical kit
11
Description
Serum LDL-C
Timepoint
Baseline and End-of-trial
Method of measurement
Laboratory clinical kit
12
Description
HDL-C سرم
Timepoint
Baseline and End-of-trial
Method of measurement
Laboratory clinical kit
13
Description
Serum Triglyceride
Timepoint
Baseline and End-of-trial
Method of measurement
Laboratory clinical kit
Intervention groups
1
Description
Intervention group: a capsule containing150 mg zinc sulfate and 250 mg magnesium oxide once a day for 3 months
Category
Treatment - Drugs
2
Description
Control group: 1000 mg Placebo capsule containing corn starch Once a day for 3 months
Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
zahra Hamedifard
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5554 0021
Email
z.hamedifard.sb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
mohsen taghizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8719675537
Phone
+98 31 5533 3213
Email
Taghizadeh_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
mohsen taghizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
871967537
Phone
+98 31 5533 3213
Email
taghizadeh_m@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data regarding demographics, anthropometric, and food variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared.
When the data will become available and for how long
The start of the data access period will be one year after the publication of the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
In order to conduct meta analysis studies
From where data/document is obtainable
Mohsen Taghizadeh, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608
What processes are involved for a request to access data/document
An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request