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The Effect of Oral Magnesium Supplementation on The Control and Outcomes of Type II Diabetes Mellitus Guided by Serum Ionized Magnesium Level: A Double-Blind Randomized Control Trial
Sponsor study identifier
interventional
247
1 country
1
Study Start
September 25, 2023
Actual (reported)Primary Completion
September 30, 2024
Actual (reported)Study Completion
September 11, 2025
Actual (reported)Studies have shown that type 2 diabetic patients (T2DM) may have low serum magnesium levels leading to poor control and outcome of the disease. Supplementation with Mg might improve overall diabetic control and disease outcome. However, there is yet no consensus on whether the ionized (iMg) or the total Mg (tMg) level should be used as a basis to determine the status of Mg in the blood. Recently it was shown that iMg may correlate better with diabetes control than tMg. Therefore, Mg supplements to diabetic patients may improve their disease status. Unfortunately, and to the best of our knowledge all of the available trials on Mg supplementation guided by iMg levels were conducted on healthy volunteers rather than T2DM patients, and they were all for a short period of time (10 days to 10 weeks). Here we hypothesize that supplementations of T2DM patients with Mg based on serum iMg levels correlate better with diabetes control and prognosis. Such hypothesis is supported by a retrospective study that concluded that iMg correlate better with BP control than tMg. In addition, another trial that investigated the effects of three Mg dietary supplements; Mg oxide, Mg citrate and Mg carbonate on healthy female young adults, showed that only Mg oxide led to an increase in the levels of iMg and tMg concentrations when compared to baseline. Furthermore, a case-control study on older diabetic patients revealed a significant association between iMg and HbA1c. This study aims to investigate the effect of supplementing Mg oxide tablets versus placebo tablets guided by serum iMg levels in T2DM patients with or without hypomagnesemia on diabetic control and prognosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 11, 2025
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 7, 2023
Actual (reported)March 17, 2023
Actual (reported)September 25, 2023
Actual (reported)September 30, 2024
Actual (reported)September 11, 2025
Actual (reported)Glycated hemoglobin (HbA1c%)
To evaluate the reduction in HbA1c% levels after 3 and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.
3-month and 12-month
Fasting Blood Glucose (FBG)
To evaluate the reduction in FBG levels after 3 and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.
3-month and 12-month
Emergency department (ED) visits, hospital admission, and length of hospital stay (LOS)
3-month and 12-month
Total dosage of insulin regimen
3-month and 12-month
Blood pressure
3-month and 12-month
lipid profile
3-month and 12-month
Serum creatinine
3-month and 12-month
Interventional group (Mg oxide supplementation): Patients in this group will receive Mg oxide tablet 500 mg (302 mg elemental), with a dosage regimen of 1 table once daily as per the recommended range of the daily dose (from 250 to 500 mg elemental) (29, 31, 41, 45). Tablets should be taken with food and 2 hrs. apart from other medications for 12 consecutive months.
Control group (placebo tablets): Patients in this group will receive placebo tablets labeled as 500 mg (302 mg elemental), with a dosage regimen of 1 tablet once daily. Tablets should be taken with food and 2 hrs. apart from other medications for 12 consecutive months.
To supplement T2DM with Mg oxide tablets (500 mg total, 302 mg elemental) regardless on their magnesium level
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mohammed AlZa'abi
Muscat, Oman
247 participants (actual enrollment reported by the registry).
First Submitted
March 7, 2023
First Posted
March 17, 2023
Contact the study team to confirm eligibility.
Study Start
September 25, 2023
Actual (reported)Primary Completion
September 30, 2024
Actual (reported)Study Completion
September 11, 2025
Actual (reported)Last Updated
September 18, 2025
Record last verified: 2025-09
the whole IPD can be shared
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Source: ClinicalTrials.gov.
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