Halawa Nihal, Elsaid Tamer Wahid, El Wakeel Lamia Mohamed, Shawki May Ahmed
Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
Nephrology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Ther Adv Chronic Dis. 2023 Dec 12;14:20406223231214641. doi: 10.1177/20406223231214641. eCollection 2023.
Magnesium (Mg) deficiency is closely linked with proteinuria.
To assess the impact of oral Mg citrate supplementation on the clinical outcome of diabetic nephropathy (DN) patients.
This was a prospective, randomized, controlled, open-label study.
Sixty DN patients were recruited from Nephrology and Endocrinology departments, Ain Shams University Hospitals, Cairo, Egypt. Patients were assigned by stratified randomization based on their Mg status, to either Mg citrate group, ( = 30), who received the standard regimen + oral Mg citrate 2.25 g/day or Control group, ( = 30), who received the standard regimen only. The primary endpoint was a change in urinary albumin to creatinine ratio (UACR) after 12 weeks. Secondary outcomes were insulin resistance, glycemic control, lipid profile, serum osteocalcin, quality of life (QoL) and Mg tolerability.
Out of a total of 60 patients enrolled, only 54 patients (26 in Mg citrate group and 28 in the control group) completed the study. Groups were comparable at baseline. The UACR median percent reduction was significantly higher in the Mg citrate group (-6.87%) (-0.9%) in the Control group, = 0.001. After 12 weeks, the estimated glomerular filtration rate significantly improved in the Mg citrate group Control group ( = 0.001). Comparable change was observed in glycemic indices. Lipid profile significantly improved in the Mg citrate group Control group ( = 0.001). Serum osteocalcin levels significantly declined in the Mg citrate group ( = 0.001) control group. Regarding QoL, the total score and all domains significantly improved in the Mg citrate group compared to control. The Mg supplement was tolerable with only mild reported side effects that required no intervention.
Oral Mg citrate supplementation improved microalbuminuria in DN patients. It also had favorable effects on serum osteocalcin, lipid profile and QoL with no reported major side effects.
ClinicalTrials.gov identifier: NCT03824379.
镁（Mg）缺乏与蛋白尿密切相关。
评估口服柠檬酸镁补充剂对糖尿病肾病（DN）患者临床结局的影响。
这是一项前瞻性、随机、对照、开放标签研究。
从埃及开罗艾因夏姆斯大学医院的肾脏病科和内分泌科招募了60例DN患者。根据患者的镁状态进行分层随机分组，分为柠檬酸镁组（n = 30），接受标准治疗方案 + 每日口服2.25 g柠檬酸镁，或对照组（n = 30），仅接受标准治疗方案。主要终点是12周后尿白蛋白与肌酐比值（UACR）的变化。次要结局包括胰岛素抵抗、血糖控制、血脂谱、血清骨钙素、生活质量（QoL）和镁耐受性。
在总共纳入的60例患者中，只有54例患者（柠檬酸镁组26例，对照组28例）完成了研究。两组在基线时具有可比性。柠檬酸镁组UACR中位数降低百分比（-6.87%）显著高于对照组（-0.9%），P = 0.001。12周后，柠檬酸镁组的估计肾小球滤过率显著优于对照组（P = 0.001）。血糖指标观察到类似变化。柠檬酸镁组的血脂谱显著优于对照组（P = 0.001）。柠檬酸镁组血清骨钙素水平显著低于对照组（P = 0.001）。关于生活质量，与对照组相比，柠檬酸镁组的总分和所有领域均显著改善。镁补充剂耐受性良好，仅报告有轻微副作用，无需干预。
口服柠檬酸镁补充剂可改善DN患者的微量白蛋白尿。它对血清骨钙素、血脂谱和生活质量也有有益影响，且未报告有重大副作用。
ClinicalTrials.gov标识符：NCT03824379。
