The effect of magnesium and creatine co-supplementation on malnutrition, quality of life and hand grip strengh in hemodialysis patients

To determine and compare serum albumin, fatigue, hand grip strength, and quality of life levels in hemodialysis patients receiving magnesium-creatine supplementation versus placebo, At baseline and after 12 weeks

A phase 3, double-blind, parallel RCT on 70 patients, with allocation into two groups via sealed envelope.

will be conducted starting in fall (1405) at Hojjatieh, Zahra-ye Marzieh, Farabi, and Amin hospitals in Isfahan. Participants will then be allocated into two groups using stratified randomization based on BMI, with an assigned code via the sealed envelope website. The intervention will receive a daily magnesium oxide and creatine supplement, while the control will receive a daily packet containing dextrose and starch, visually similar in appearance to the magnesium-creatine supplement. None of the individuals involved in the intervention process are aware of the group assignments.

Inclusion Criteria: On hemodialysis for ≥3 months Dialysis ≥ 3 times/week mg < 1.5 mmol/L Not enrolled in another study Not pregnant or breastfeeding No cancer, advanced liver disease, bipolar disorder, or heart failure No recent (past month) use/dose change of drugs/supplements affecting outcomes (e.g., L-carnitine, protein supplements, albumin, nutritional supplements) No enteral/parenteral nutrition Age ≥18 Not a kidney transplant candidate Exclusion Criteria: Change in dialysis type Onset of cachexia-causing illness (e.g., cancer, AIDS, Kidney transplant) Use of drugs/supplements affecting outcomes In the event of adverse effects occurring, and if the individual is unwilling to continue with the intervention

Intervention: 200 mg magnesium oxide, 2 g creatine, and 1 g dextrose Control: 1 g dextrose and 2 g starch.

serum albumin, fatigue, hand grip strength, and quality of life

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.

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.