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

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ClinicalTrials.gov Identifier: NCT02163070
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : January 9, 2015
Sponsor:
Collaborator:
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Mohammad Hassan Eftekhari, Shiraz University of Medical Sciences

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: whey drink, Dietary Supplement: whey drink fortified with vitaminE Dietary Supplement: vitamin E Phase 2

Detailed Description:

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:

  1. consumption of 220 milliliters of whey drink three times a week,
  2. consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
  3. consumption of 400 milligrams of vitamin E three times a week,
  4. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014


Arm Intervention/treatment
Experimental: whey drink
consumption of 220 milliliters of whey drink three times a week,
Dietary Supplement: whey drink,
consumption of 220 milliliters of whey drink three times a week,

Experimental: whey drink fortified with vitaminE
consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
Dietary Supplement: whey drink fortified with vitaminE
consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,

Experimental: vitaminE
consumption of 400 milligrams of vitamin E three times a week,
Dietary Supplement: vitamin E
consumption of 400 milligrams of vitamin E three times a week,

No Intervention: D- control
control group: no intervention,



Primary Outcome Measures :
  1. malnutrition (based on SGA assessment) [ Time Frame: 2 months (8 weeks) ]
  2. Malnutrition inflammation score [ Time Frame: 2 months (8 weeks) ]

Secondary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163070


Sponsors and Collaborators
Mohammad Hassan Eftekhari
Shiraz University of Medical Sciences
Investigators
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Study Director: Mohammad Hassan Eftekhari, professor Shiraz University of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohammad Hassan Eftekhari, professor. PhD, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02163070    
Other Study ID Numbers: 91-6424
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015
Keywords provided by Mohammad Hassan Eftekhari, Shiraz University of Medical Sciences:
whey protein
malnutrition
oxidative stress
hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamins
Vitamin E
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents