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Investigating the effect of protein nutritional supplements on erythropoietin resistance in individuals with protein-energy wasting syndrome undergoing hemodialysis

Investigating the effect of protein nutritional supplements on erythropoietin resistance in individuals with protein-energy wasting syndrome undergoing hemodialysis at Imam Hussein Hospital: A randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210301050546N1
Enrollment
50
Registered
2025-08-02
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with protein energy wasting syndrome undergoing hemodialysis. Chronic kidney disease, unspecified

Interventions

Intervention 1: Intervention group: 25 patients, as prescribed and under the supervision of a nutritionist and nephrologist, use VM protein powder for three months. VM-protein 24 grams orally, manufac

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with chronic kidney disease (CKD) who are undergoing chronic hemodialysis for at least 6 months. Diagnosis of protein-energy wasting syndrome based on international criteria Weight loss = 5% in the last 3 months or body mass index less than 23 Decreased muscle mass based on BIA measurement or SGA index Decreased serum albumin (<3.8 g/dL) or decreased serum TIBC level (<200 mg/dL) Reduced energy and protein intake (<25 kcal/kg/day and <1.0 g/kg/day) Receiving erythropoietin treatment for at least the last 3 months Written consent to participate in the study

Exclusion criteria

Exclusion criteria: Acute inflammatory diseases or active infections Malignant diseases (active cancer) or receiving chemotherapy Anemia due to non-renal causes (MDS hemoglobinopathy) Taking steroids or immunosuppressant drugs

Design outcomes

Primary

MeasureTime frame
Serum erythropoietin changes. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination.;Erythropoietin resistance index. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination.;Serum hemoglobin level. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination.;Changes in serum albumin and TIBC levels. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination.;Changes in serum ferritin levels. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination.;CRP and ESR changes. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: Blood sample and laboratory examination.;Changes in body analysis indicators. Timepoint: At the beginning of the study and three months after consuming the protein powder. Method of measurement: InBody S10 device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGhazale Ghorbani Garakani

Shahid Beheshti University of Medical Sciences

ghazaal.ghorbani.1@gmail.com+98 21 2286 3637

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026