Protocol summary
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Study aim
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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 .
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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The primary outcome is insulin resistance and the secondary consequences of changes in the metabolic profile; inflammatory factors and oxidative stress biomarkers.
General information
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Reason for update
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The updating process was done before publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130211012438N31
Registration date:
2019-05-11, 1398/02/21
Registration timing:
retrospective
Last update:
2020-05-27, 1399/03/07
Update count:
1
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Registration date
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2019-05-11, 1398/02/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-05, 1397/10/15
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Expected recruitment end date
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2019-01-20, 1397/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of magnesium and zinc co-supplementation on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus
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Public title
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The effect of magnesium and zinc co-supplementation in patients with coronary heart disease and type 2 diabetes mellitus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 95 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-10, 1397/09/19
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1397.079
Health conditions studied
1
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Description of health condition studied
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coronary heart disease and type 2 diabetes mellitus
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ICD-10 code
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I25.9
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ICD-10 code description
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Chronic ischemic heart disease, unspecified
Primary outcomes
1
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Description
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HOMA-Index
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Formula calculation
Secondary outcomes
1
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Description
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Fasting plasma glucose
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Timepoint
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Fasting plasma glucose
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Method of measurement
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Enzymatic
2
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Description
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Insulin
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Timepoint
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Baseline and End-of-tria
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Method of measurement
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Elisa
3
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Description
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QUICKI
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Timepoint
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Baseline and End-of-tria
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Method of measurement
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Formula calculation
4
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Description
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Beck Depression Inventory
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Timepoint
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Baseline and End-of-tria
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Method of measurement
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Questionnaire
5
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Description
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Nitric oxide (NO)
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Timepoint
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Baseline and End-of-tria
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Method of measurement
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Spectrophotometry
6
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Description
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High sensitivity C-reactive protein (hs-CRP)
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Timepoint
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Baseline and End-of-tria
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Method of measurement
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Elisa
7
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Description
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Total Antioxidant Capacity (TAC)
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
8
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Description
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Total glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
9
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Description
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Malondialdehyde(MDA)
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
10
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Description
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Serum Total cholestrol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Laboratory clinical kit
11
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Description
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Serum LDL-C
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Laboratory clinical kit
12
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Description
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HDL-C سرم
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Laboratory clinical kit
13
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Description
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Serum Triglyceride
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Laboratory clinical kit
14
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Description
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Beck Anxiety Inventory
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: a capsule containing150 mg zinc sulfate and 250 mg magnesium oxide once a day for 3 months
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Category
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Treatment - Drugs
2
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Description
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Control group: 1000 mg Placebo capsule containing corn starch Once a day for 3 months
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available