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Completed

NCT Number: NCT02163070

Effect of Vitamin E Fortified Whey Drink on Nutritional, Inflammatory and Oxidative Markers in Hemodialysis Patients

The purpose of the study is to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients

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Key information

About this study

The aim of this interventional study was to evaluate the effect of vitamin E fortified whey drink on nutritional status, inflammatory markers and oxidative stress in hemodialysis patients. 92 hemodialysis patients were selected for the study. Inclusion criteria included: mean age of 17-65 years old; having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment; being dialyzed at least 2 times a week for 3 months. Exclusion criteria included: hospitalization in the last month; active infection; using immunosuppressant drugs or multi-vitamins; pregnancy. The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.Informed consent were signed by all of them for participating in the study. Weight and height of the patients were recorded for BMI (body mass index) calculation. Then, all of the patients were assigned into 4 groups:

  • consumption of 220 milliliters of whey drink three times a week,
  • consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
  • consumption of 400 milligrams of vitamin E three times a week,
  • control group: no intervention. Patients were followed for 2 months. At the beginning and the end of the 2-month intervention period, 10 milliliters of blood were taken from all of the patients and nutritional status of the patients were assessed as the primary outcome. Serum levels of malondialdehyde, c-reactive protein, albumin, transferrin and lipoproteins were also measured. SGA, MIS and SF-12 questionnaires were filled for all of the patients at the beginning and the end of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mean age of 17-65 years old;
  • having mild, moderate or severe malnutrition based on the SGA (subjective global assessment) assessment;
  • be dialyzed at least 2 times a week for 3 months

Exclusion criteria

  • hospitalization in the last month;
  • active infection;
  • using immunosuppressant drugs or multi-vitamins;
  • pregnancy, consuming whey or soy products

Treatment and study plan

whey drink,

Dietary Supplement

consumption of 220 milliliters of whey drink three times a week,

whey drink fortified with vitaminE

Dietary Supplement

consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,

Vitamin E

Dietary Supplement

consumption of 400 milligrams of vitamin E three times a week,

Primary outcomes

  1. malnutrition (based on SGA assessment)

    Time frame: 2 months (8 weeks)

  2. Malnutrition inflammation score

    Time frame: 2 months (8 weeks)

Secondary outcomes

  1. serum interleukin-6

    Time frame: 2 months (8 weeks)

  2. serum C-reactive protein

    Time frame: 2 months (8 weeks)

  3. serum albumin

    Time frame: 2 months (8 weeks)

  4. serum HDL-c

    Time frame: 2 months (8 weeks)

  5. serum total cholesterol

    Time frame: 2 months (8 weeks)

  6. serum triglyceride

    Time frame: 2 months (8 weeks)

  7. serum transferrin

    Time frame: 2 months (8 weeks)

  8. serum malondialdehyde

    Time frame: 2 months (8 weeks)

  9. BUN (blood urea nitrogen)

    Time frame: 2 months (8 weeks)

  10. serum creatinine

    Time frame: 2 months (8 weeks)

  11. serum calcium

    Time frame: 2 months (8 weeks)

  12. serum phosphate

    Time frame: 2 months (8 weeks)

  13. quality of life

    Time frame: 2 months (8 weeks)

  14. weight

    Time frame: 2 months (8 weeks)

  15. height

    Time frame: 2 months (8 week)

  16. Body mass index

    Time frame: 2 months (8 weeks)

Sponsors and collaborators

Lead sponsor

Mohammad Hassan Eftekhari

Other

Collaborators

  • Shiraz University of Medical Sciences

Registry information

Official study title

Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients

Acronym: EVEWD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 13, 2014
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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