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

Chronic Kidney Disease Clinical Trial

— EVEWD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163070
• Other study ID #: 91-6424
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2014
• Last updated: January 8, 2015
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mohammad Hassan Eftekhari	Shiraz University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	malnutrition (based on SGA assessment)		2 months (8 weeks)	No
Primary	Malnutrition inflammation score		2 months (8 weeks)	No
Secondary	serum interleukin-6		2 months (8 weeks)	No
Secondary	serum C-reactive protein		2 months (8 weeks)	No
Secondary	serum albumin		2 months (8 weeks)	No
Secondary	serum HDL-c		2 months (8 weeks)	No
Secondary	serum total cholesterol		2 months (8 weeks)	No
Secondary	serum triglyceride		2 months (8 weeks)	No
Secondary	serum transferrin		2 months (8 weeks)	No
Secondary	serum malondialdehyde		2 months (8 weeks)	No
Secondary	BUN (blood urea nitrogen)		2 months (8 weeks)	No
Secondary	serum creatinine		2 months (8 weeks)	No
Secondary	serum calcium		2 months (8 weeks)	No
Secondary	serum phosphate		2 months (8 weeks)	No
Secondary	quality of life		2 months (8 weeks)	No
Secondary	weight		2 months (8 weeks)	No
Secondary	height		2 months (8 week)	No
Secondary	Body mass index		2 months (8 weeks)	No