The Effect of Oral Nutritional protein Supplement on Nutritional Status and protein energy wasting of Hemodialysis Patients : a randomized double-blind, placebo-controlled trial

Investigating the effect of protein nutrition supplements on the improvement of protein energy loss and nutritional status of hemodialysis patients referred to Imam Hossein Hospital in 1402

In this clinical trial, 52 patients undergoing hemodialysis were randomly assigned into two groups receiving vm protein supplement and placebo. In the intervention group, according to the prescription and under the supervision of a nutritionist and nephrologist, vm protein powder is used for six months.

Patients with chronic kidney disease under routine hemodialysis diagnosed with protein-energy wasting referred to Imam Hossein hospital in Tehran in 1402

Inclusion criteria: including the age range of 20 to 70 years, albumin less than 4 gr/dl, at least 6 months under treatment with Hemodialysis, performing hemodialysis at least twice a week, malnourished patients who are undergoing hemodialysis and have a score of 1 or higher according to the MUST questionnaire. Exclusion criteria Severe heart and respiratory failure, chronic inflammatory disease with known origin, chronic liver disease, nephrotic syndrome, cancer, dementia, neurological disease, hepatitis B, hepatitis C, HIV, active and acute infection in the last 4 weeks, recent surgery in the last three months or during follow-up, malignancy Accompanying and hospitalization in the last 3 months that may affect the nutritional or functional status was not using parenteral nutrition and oral supplements.

Consumption of VM-protein in the amount of 24 grams orally manufactured by Iran Daru Company for six months on a daily basis (within 6 months from the beginning of the study)

Improving the state of energy protein loss

All eligible people will be randomly assigned to one of the two groups to receive medicine or placebo with a ratio of 1:1. The randomization method will be permuted block randomization, and the blocks will be based on the sample size in sizes 2, 4, 6, 8, 10 or more using the "Ralloc" package in STATA software. Patients will be included in each group based on the determined sample size and based on the list of randomized individuals (along with a specific research code for each individual).

This study is double-blind. The medicine and placebo needed for the people participating in the study will be sent to the treatment center from the manufacturing company in a completely covered and indistinguishable form for use by patients. The people participating in the study and the clinical evaluators of the patients (specialist doctors) will not be aware of the drug or placebo.

All data is potentially shareable after de-identifying individuals

The access period starts 6 months after the results are published

Researchers working in academic institutions

Statistical analyzes are performed on the delivered data

Dialysis Department of Imam Hossein Hospital

After a period of 6 months