Clinical trial NCT02163070: Effect of Vitamin E Fortified Whey Drink on Nutritional, Inflammatory and Oxidative Markers in Hemodialysis Patients
Official title: Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: whey protein
malnutrition
oxidative stress
hemodialysis
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shiraz University of Medical Sciences
First posted: 2014-06-13
Enrollment: 92
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: malnutrition (based on SGA assessment)
timeFrame: 2 months (8 weeks)
measure: Malnutrition inflammation score
timeFrame: 2 months (8 weeks)
Secondary outcomes:
measure: serum interleukin-6
timeFrame: 2 months (8 weeks)
measure: serum C-reactive protein
timeFrame: 2 months (8 weeks)
measure: serum albumin
timeFrame: 2 months (8 weeks)
measure: serum HDL-c
timeFrame: 2 months (8 weeks)
measure: serum total cholesterol
timeFrame: 2 months (8 weeks)
measure: serum triglyceride
timeFrame: 2 months (8 weeks)
measure: serum transferrin
timeFrame: 2 months (8 weeks)
measure: serum malondialdehyde
timeFrame: 2 months (8 weeks)
measure: BUN (blood urea nitrogen)
timeFrame: 2 months (8 weeks)
measure: serum creatinine
timeFrame: 2 months (8 weeks)
measure: serum calcium
timeFrame: 2 months (8 weeks)
measure: serum phosphate
timeFrame: 2 months (8 weeks)
measure: quality of life
timeFrame: 2 months (8 weeks)
measure: weight
timeFrame: 2 months (8 weeks)
measure: height
timeFrame: 2 months (8 week)
measure: Body mass index
timeFrame: 2 months (8 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Mohammad Hassan Eftekhari, professor
role: STUDY_DIRECTOR
References:
citation: Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.