Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of magnesium supplementation on carotid intima-media thickness (CIMT) and metabolic profiles in diabetic hemodialysis patients.
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Design
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Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive magnesium supplement (n=30) or placebo (n=30).
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Settings and conduct
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Among diabetic hemodialysis patients referred to Yasrebi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 24 weeks after the intervention. At the beginning and the end of the intervention: 24 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diabetic hemodialysis patients aged 18 to 80 years will be included in the study.Exclusion criteria: Patients with inflammatory and malignant diseases, taking magnesium supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study, taking immunosuppressive agents
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Intervention groups
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Intervention group: Magnesium supplements (21st Century Pharmaceutical Company, Arizona, USA), 250 mg, one capsule for 24 weeks orally. Control group: placebo (Barij Essence, Kashan, Iran), one capsule for 24 weeks orally.
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Main outcome variables
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Outcomes: Carotid intima-media thickness (primary outcome) and metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017090133941N19
Registration date:
2017-11-20, 1396/08/29
Registration timing:
prospective
Last update:
2020-08-02, 1399/05/12
Update count:
2
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Registration date
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2017-11-20, 1396/08/29
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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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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-12-01, 1396/09/10
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Expected recruitment end date
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2017-12-10, 1396/09/19
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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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Clinical trial of the effect of magnesium supplementation compared with the placebo on carotid intima-media thickness and metabolic profiles in diabetic hemodialysis patients
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Public title
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Effect of magnesium supplementation in treatment of diabetic hemodialysis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diabetic hemodialysis patients
Aged 18 to 80 years
Exclusion criteria:
Patients with inflammatory and malignant diseases
Taking magnesium supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study
Taking immunosuppressive agents
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Age
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From 18 years old to 80 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
- Investigator
- Outcome assessor
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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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At study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<50 and ≥50 y), subjects will be randomly divided into two groups to receive supplement or placebo. Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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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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2017-10-19, 1396/07/27
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.69
Health conditions studied
1
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Description of health condition studied
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Hemodialysis
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ICD-10 code
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N18
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ICD-10 code description
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Chronic kidney disease
Primary outcomes
1
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Description
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Mean left CIMT
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Sonography
2
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Description
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Maximum left CIMT
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Sonography
3
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Description
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Mean right CIMT
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Sonography
4
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Description
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Maximum right CIMT
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
3
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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HDL
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Elisa kit
7
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Intervention group: 250 mg magnesium (21st Century Pharmaceutical Company, Arizona, USA), daily for 24 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran), daily for 24 weeks orally.
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Category
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Treatment - Drugs
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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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable