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IRCT20130903014551N15 IRCT 2026-08-07 Esfahan University of Medical Sciences The effect of magnesium and creatine co-supplementation on malnutrition, quality of life and hand grip strengh in hemodialysis patients The effect of magnesium and creatine co-supplementation on malnutrition, quality of life and hand grip strengh in hemodialysis patients 2026-09-06 anticipated 70 Recruiting https://irct.ir/trial/92218 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the code assigned to each individual, participants will be randomly divided into intervention and control groups using stratified randomization based on BMI (25<BMI<18.5 and BMI≥25) via the sealed envelope website. To conceal the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, after generating the random sequence, a number of opaque envelopes corresponding to the study's sample size will be prepared, and each of the generated random sequences will be recorded on a card; the cards will then be placed inside the envelopes in order. To preserve the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the envelopes will be sealed and, separated by BMI classification, placed in order inside boxes. At the start of participant enrollment, based on the order in which eligible participants enter the study, the envelopes will be opened sequentially, revealing the assigned group for that participant, Blinding description: All steps of randomization and allocation concealment will be carried out by a third party. The intervention group will receive one daily packet of supplement containing 200 mg of magnesium oxide, 2 g of creatine, and 1 g of dextrose (to improve taste), while the control group will receive one daily packet containing 1 g of dextrose and 2 g of starch, which will be visually similar in appearance to the magnesium-creatine supplement used. 3 Chronic Kidney Disease (CKD) Requiring Hemodialysis. Intervention 1: Intervention group:The intervention group will receive one daily packet of supplement containing 200 mg magnesium oxide, 2 g creatine, and 1 g dextrose (to improve taste), The supplements used in the intervention and placebo groups will be prepared in identical sachet form. The supplement/placebo will be taken once daily after breakfast, and on dialysis days, intake will be scheduled after the first meal following the dialysis session. The study duration will be 12 weeks. To assess adherence, patients will be met with and monitored weekly, with each visit lasting 20 minutes. Every two weeks, supplements/placebo for the next 14 days will be given to participants, and the empty packets from the previous period will be collected. Patients will also be contacted via social media/messaging platforms. Additionally, a checklist will be given to patients to mark each time they take the supplement or placebo. However, to assess dietary intake — a confounding factor in this study — six 24-hour dietary recalls will be used. One dietary recall will be taken at the beginning of the study, before the intervention begins. The remaining six dietary recalls will be taken at weeks 2, 4, 6, 8, 10, and 12, divided into 4 regular days and 2 dialysis days. Participants will be asked not to change their diet. Patients in both groups will receive a list of dietary recommendations relevant to hemodialysis patients. Serum albumin levels, fatigue, muscle mass and function, quality of life, will be measured at the beginning and end of the study. Intervention 2: Control group: The supplements used in the intervention and placebo groups will be prepared in identical sachet form. The supplement/placebo will be taken once daily after breakfast, and on dialysis days, intake will be scheduled after the first meal following the dialysis session. The study duration will be 12 weeks. To assess adherence, patients will be met with and monitored weekly, with each visit lasting 20 minutes. Every two weeks, supplements/placebo for the next 14 days will be given to participants, and the empty packets from the previous period will be collected. Patients will also be contacted via social media/messaging platforms. Additionally, a checklist will be given to patients to mark each time they take the supplement or placebo. However, to assess dietary intake — a confounding factor in this study — six 24-hour dietary recalls will be used. One dietary recall will be taken at the beginning of the study, before the intervention begins. The remaining six dietary recalls will be taken at weeks 2, 4, 6, 8, 10, and 12, divided into 4 regular days and 2 dialysis days. Participants will be asked not to change their diet. Patients in both groups will receive a list of dietary recommendations relevant to hemodialysis patients. Serum albumin levels, fatigue, muscle mass and function, quality of life, will be measured at the beginning and end of the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no more information
public Mohammad Hossein Rouhani
Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 s_m_rouhani2003@yahoo.com Esfahan University of Medical Sciences scientific Mohammad Hossein Rouhani
Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 s_m_rouhani2003@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Have been undergoing hemodialysis treatment for at least 3 months. Undergo dialysis 3 times per week. Not have hypermagnesemia (Mg > 1.5 mmol/L) Not be enrolled in any other study. Not be pregnant or breastfeeding. Not have other diseases such as cancer, advanced liver disease, bipolar disorder, or heart failure. Not be taking medications or supplements that affect the dependent variables — such as L-carnitine, protein supplements, albumin vials, or any type of nutritional supplement — that they started or changed the dosage of within the past month. Not be receiving enteral or parenteral nutrition. Be 18 years of age or older. Not be a candidate for kidney transplant surgery. 18 years no limit Both Change in the type of dialysis. Development of diseases that lead to cachexia and loss of muscle mass, such as cancer, AIDS and Kidney transplantation Use of medications or supplements affecting the dependent variables. If the individual shows adverse effects related to the supplement, the adverse event will be reported, and if the individual is unwilling to continue the intervention, they will be withdrawn from the study. Dependence Z99.2 Treatment - Other Treatment - Other Intervention group:The intervention group will receive one daily packet of supplement containing 200 mg magnesium oxide, 2 g creatine, and 1 g dextrose (to improve taste), The supplements used in the intervention and placebo groups will be prepared in identical sachet form. The supplement/placebo will be taken once daily after breakfast, and on dialysis days, intake will be scheduled after the first meal following the dialysis session. The study duration will be 12 weeks. To assess adherence, patients will be met with and monitored weekly, with each visit lasting 20 minutes. Every two weeks, supplements/placebo for the next 14 days will be given to participants, and the empty packets from the previous period will be collected. Patients will also be contacted via social media/messaging platforms. Additionally, a checklist will be given to patients to mark each time they take the supplement or placebo. However, to assess dietary intake — a confounding factor in this study — six 24-hour dietary recalls will be used. One dietary recall will be taken at the beginning of the study, before the intervention begins. The remaining six dietary recalls will be taken at weeks 2, 4, 6, 8, 10, and 12, divided into 4 regular days and 2 dialysis days. Participants will be asked not to change their diet. Patients in both groups will receive a list of dietary recommendations relevant to hemodialysis patients. Serum albumin levels, fatigue, muscle mass and function, quality of life, will be measured at the beginning and end of the study. Control group: The supplements used in the intervention and placebo groups will be prepared in identical sachet form. The supplement/placebo will be taken once daily after breakfast, and on dialysis days, intake will be scheduled after the first meal following the dialysis session. The study duration will be 12 weeks. To assess adherence, patients will be met with and monitored weekly, with each visit lasting 20 minutes. Every two weeks, supplements/placebo for the next 14 days will be given to participants, and the empty packets from the previous period will be collected. Patients will also be contacted via social media/messaging platforms. Additionally, a checklist will be given to patients to mark each time they take the supplement or placebo. However, to assess dietary intake — a confounding factor in this study — six 24-hour dietary recalls will be used. One dietary recall will be taken at the beginning of the study, before the intervention begins. The remaining six dietary recalls will be taken at weeks 2, 4, 6, 8, 10, and 12, divided into 4 regular days and 2 dialysis days. Participants will be asked not to change their diet. Patients in both groups will receive a list of dietary recommendations relevant to hemodialysis patients. Serum albumin levels, fatigue, muscle mass and function, quality of life, will be measured at the beginning and end of the study. Serum albumin. Timepoint: Measurement of serum albumin before the intervention begins and at the end of the twelfth week. Method of measurement: Blood sample and using the Bromocresol Green method. En Fatigue levels. Timepoint: Measurement of fatigue levels before the intervention begins and at the end of the twelfth week. Method of measurement: پرسشنامه MFI-20. Handgrip strength. Timepoint: Measurement of handgrip strength before the intervention begins and at the end of the twelfth week. Method of measurement: En Based on the Southampton method using the handgrip device (SH5002 SAEHAN Spring). Quality of life levels. Timepoint: Measurement of quality of life levels before the intervention begins and at the end of the twelfth week. Method of measurement: Kidney Disease Quality of Life Questionnaire (KDQOL). Esfahan University of Medical Sciences Approved 2026-08-02 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)