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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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whey drink fortified with vitaminE

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

Group Type EXPERIMENTAL

whey drink fortified with vitaminE

Intervention Type DIETARY_SUPPLEMENT

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

vitaminE

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

Group Type EXPERIMENTAL

vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

D- control

control group: no intervention,

Group Type NO_INTERVENTION

No interventions assigned to this group

whey drink

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

Group Type EXPERIMENTAL

whey drink,

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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whey drink,

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

Intervention Type 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,

Intervention Type DIETARY_SUPPLEMENT

vitamin E

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No