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IRCT20170202032367N14 IRCT 2026-09-07 Tehran University of Medical Sciences The Effect of Inositol Supplementation on Inflammation, Fatigue, and Metabolic Status in Patients with Type 2 Diabetes and Chronic Kidney Disease INS-CKD Evaluation of the Effects of Inositol Supplementation on inflammatory status, oxidative stress, fatigue, and insulin resistance and lipid profile in type 2 diabetic patients with chronic kidney disease: Double-blind randomized clinical trial (RCT) 2026-09-23 anticipated 48 Recruiting https://irct.ir/trial/93008 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After completion of the run-in period and baseline assessments, eligible participants will be randomly allocated to the intervention and control groups. Stratified block randomization will be used for allocation. The unit of randomization will be the individual participant. Participants will first be stratified according to sex (male/female) and age, and then within each stratum, they will be randomly assigned to the intervention group (inositol supplementation) or control group (placebo) using blocks of four. The random allocation sequence will be generated using statistical software. Group allocation will remain concealed from investigators and participants until the initiation of the intervention, Blinding description: This study will be conducted as a double-blind clinical trial. Participants, investigators, care providers, and outcome assessors will be blinded to the group allocation. The inositol supplement and placebo will be identical in appearance, packaging, and administration method. To maintain blinding, the supplements and placebo will be coded by an individual who is not involved in participant assessment or data analysis. Participants will not be informed whether they receive inositol supplementation or placebo during the study period. Individuals responsible for intervention delivery, data collection, clinical and laboratory assessments, and outcome evaluation will remain unaware of participants’ group assignments. The allocation codes will remain concealed from investigators and data analysts until completion of data collection and final statistical analysis. The codes will be revealed after completion of the final analysis. N/A Condition 1: Type 2 diabetes mellitus. Condition 2: Chronic kidney disease, stage 3. Condition 3: Chronic kidney disease, stage 4. Intervention 1: Participants in the intervention group will receive the IP-6 product (Inositol Hexaphosphate) marketed under the brand name M Plus IP-6. Each tablet contains 800 mg of inositol hexaphosphate. Participants will take two tablets daily, equivalent to 1,600 mg per day, for 8 weeks. The product will be administered according to the study protocol. This product is manufactured under the M Plus brand and is commercially available in Iran. Intervention 2: Participants in the control group will receive a placebo identical in appearance, color, and packaging to the intervention product but containing no active ingredient (inositol hexaphosphate). The placebo will be administered in the same manner as the intervention, with participants taking two tablets daily in two divided doses (morning and evening) for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of participants’ clinical and personal information and adherence to ethical research principles, individual participant data will not be shared.
public Hossein Imani
No. 44, Hojat Doost Alley, Naderi Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5742 H-imani@sina.tums.ac.ir Tehran University of Medical Sciences scientific Hossein Imani
No. 44, Hojat Doost Alley, Naderi Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5742 H-imani@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age >20 and <60 years. Body mass index (BMI) >20 and <30 kg/m². Willingness to participate in the study. Pre-dialysis chronic kidney disease (CKD) stage 3 or 4, diagnosed based on laboratory findings and confirmed by a nephrologist. 20 years 60 years Both Use of glucocorticoids, antibiotics, fluvoxamine, non-steroidal anti-inflammatory drugs (NSAIDs), or warfarin. Current cigarette smoking. History of hospitalization within the past 3 months. History of any autoimmune diseases, thyroid disorders, or malignancies. Use of antioxidant supplements within the past 3 months. Pregnancy, intention to become pregnant, or breastfeeding within the next 2 months. E11.9 N18.3 N18.4 Type 2 diabetes mellitus without complications Chronic kidney disease, stage 3 (moderate) Chronic kidney disease, stage 4 (severe) Treatment - Other Placebo Participants in the intervention group will receive the IP-6 product (Inositol Hexaphosphate) marketed under the brand name M Plus IP-6. Each tablet contains 800 mg of inositol hexaphosphate. Participants will take two tablets daily, equivalent to 1,600 mg per day, for 8 weeks. The product will be administered according to the study protocol. This product is manufactured under the M Plus brand and is commercially available in Iran. Participants in the control group will receive a placebo identical in appearance, color, and packaging to the intervention product but containing no active ingredient (inositol hexaphosphate). The placebo will be administered in the same manner as the intervention, with participants taking two tablets daily in two divided doses (morning and evening) for 8 weeks. Changes in tumor necrosis factor alpha level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of tumor necrosis factor alpha level using a specific laboratory assay kit. Changes in interleukin 6 level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of interleukin 6 level using a specific laboratory assay kit. Changes in total antioxidant capacity. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of serum total antioxidant capacity using a laboratory method and commercial assay kit. Changes in malondialdehyde level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of serum malondialdehyde level using a laboratory method and commercial assay kit. Changes in fatigue score. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Assessment of fatigue using the Fatigue Assessment Scale questionnaire. Changes in triglyceride glucose index. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Calculation of triglyceride glucose index based on laboratory measurements of triglycerides and fasting blood glucose. Changes in insulin resistance index. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Calculation of insulin resistance index based on fasting blood glucose and fasting insulin. Changes in insulin sensitivity index. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Calculation of insulin sensitivity index based on fasting blood glucose and fasting insulin. Changes in fasting blood glucose level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of fasting blood glucose using a standard laboratory method. Changes in fasting insulin level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of fasting insulin level using a specific laboratory assay kit. Changes in total cholesterol level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of serum total cholesterol using a standard laboratory method. Changes in triglyceride level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of serum triglyceride using a standard laboratory method. Changes in low-density lipoprotein level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of serum low-density lipoprotein using a standard laboratory method. Changes in high-density lipoprotein level. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of serum high-density lipoprotein using a standard laboratory method. Changes in systolic blood pressure. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of systolic blood pressure using a standard blood pressure monitor. Changes in diastolic blood pressure. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of diastolic blood pressure using a standard blood pressure monitor. Changes in body weight. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Measurement of body weight using a standard scale. Changes in body mass index. Timepoint: At baseline (before intervention) and after 8 weeks of intervention. Method of measurement: Calculation of body mass index based on measured body weight and height. Changes in dietary intake. Timepoint: At baseline, week 4, and end of week 8 of intervention. Method of measurement: Assessment of dietary intake using 24-hour dietary recalls including two non-holiday days and one holiday. Changes in physical activity level. Timepoint: At baseline, week 4, and end of week 8 of intervention. Method of measurement: Assessment of physical activity level using a physical activity questionnaire. Tehran University of Medical Sciences Approved 2026-09-03 Dr. Shariati Educational, Research and Therapeutic Center – Tehran University of Medical Sciences (R No. 44, Hojatdoost Alley, Naderi Street, Keshavarz Boulevard, Tehran, Iran – Department of Clinical Nutrition, 5th Floor, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences tehran Tehran Iran (Islamic Republic of)