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Effects of protein supplementation in nutritional status of hemodialysis patients

Effects of oral supplementation with albumin in nutritional status of hemodialysis patients: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8r4jpg
Enrollment
Unknown
Registered
2018-04-29
Start date
2017-05-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Chronic Renal Failure, dialysis.

Interventions

After signing the informed consent form, the subjects were randomized according to sex, age, and protein intake using the protein equivalent of Nitrogen (NAP) and divided into two groups: Control Grou
Dietary supplement
SP6.051.227

Sponsors

Faculdade de Nutrição da Universidade Federal de Goiás
Lead Sponsor
Centro de Nefrologia - Centrel
Collaborator
Faculdade de Nutrição da Universidade Federal de Goiás
Collaborator

Eligibility

Age
20 Years to 79 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria adopted for participation in the study were: patients of both sexes, aged between 20 and 79 years, for at least three months on hemodialysis treatment, performing three sessions per week.

Exclusion criteria

Exclusion criteria: The exclusion criteria were: bedridden patients; Amputees; Patients with decompensated diabetes; Pregnant women; Who are consuming nutritional supplements containing protein; Food intolerance or allergy to egg white protein; Liver disease, intestinal malabsorption, cancer and Acquired Immunodeficiency Syndrome.

Design outcomes

Primary

MeasureTime frame
Improvement of body composition with preservation of muscle mass, assessed by electrical bioimpedance. Outcomes were assessed 1 week before and after the intervention. The statistical power associated to the sample size estimated by the mean of the difference in muscle mass of 20 patients from the control (pilot) group was calculated. The sample calculation was estimated in 24 participants, with a level of significance of 5% and statistical power of 80% for a difference of 0.5 kg in muscle mass as significant.;The intervention had no effect on muscle mass (p=0.351).

Secondary

MeasureTime frame
Improvement of inflammatory markers, evaluated by biochemical tests of C-reactive protein (CRP) and Interleukin 6 (IL-6). Outcomes were assessed 1 week before and after the intervention. Increased quality of life, assessed by means of the questionnaire of specific quality of life for chronic kidney disease. Outcomes were assessed 15 days before and after the intervention.;Analysis of the inflammatory markers will still be performed.;Protein supplementation improved the dimension of "symptoms and problems" related to CKD, of the quality of life questionnaire (p=0.028).

Countries

Brazil

Contacts

Public ContactGleicy;Maria Fernandes Nunes;Gondim Peixoto

Faculdade de Nutrição da Universidade Federal de Goiás;Faculdade de Nutrição da Universidade Federal de Goiás

gleicynutri@gmail.com;mrg.peixoto@uol.com.br5562991818748;5562981422300

Outcome results

None listed

Source: REBEC (via WHO ICTRP)