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

Mohammad Hassan Eftekhari

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Dietary Supplement: vitamin E; Dietary Supplement: whey drink fortified with vitaminE; Dietary Supplement: whey drink,

Study type: Interventional

Funder types: Other

Identifiers

NCT02163070

91-6424

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 17 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 4 patient groups

whey drink

Experimental group

Description:

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

Treatment:

Dietary Supplement: whey drink,

whey drink fortified with vitaminE

Experimental group

Description:

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

Treatment:

Dietary Supplement: whey drink fortified with vitaminE

vitaminE

Experimental group

Description:

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

Treatment:

Dietary Supplement: vitamin E

D- control

No Intervention group

Description:

control group: no intervention,