Chronic Kidney DiseasePhase 2EVEWDNCT02163070
Effect of Vitamin E Fortified Whey Drink on Nutritional, Inflammatory and Oxidative Markers in Hemodialysis Patients
A Phase 2 study testing whey drink,, whey drink fortified with vitaminE and vitamin E in people with Chronic Kidney Disease, run by Mohammad Hassan Eftekhari.
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 Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- whey drink,, whey drink fortified with vitaminE and vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- hospitalization in the last month;
- active infection;
- using immunosuppressant drugs or multi-vitamins;
- pregnancy, consuming whey or soy products
About this study
Official title: Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients
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
Read the 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:
- consumption of 220 milliliters of whey drink three times a week,
- consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
- consumption of 400 milligrams of vitamin E three times a week,
- 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
- Chronic Kidney Disease
- Being tested
- whey drink,, whey drink fortified with vitaminE, vitamin E
- Keywords
- whey protein, malnutrition, oxidative stress, hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey drink,Dietary supplement
consumption of 220 milliliters of whey drink three times a week,
whey drink fortified with vitaminEDietary supplement
consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
vitamin EDietary supplement
consumption of 400 milligrams of vitamin E three times a week,
| Study group | Role | What they receive |
|---|---|---|
| whey drink | Experimental | consumption of 220 milliliters of whey drink three times a week, Receives: Dietary Supplement: whey drink, |
| whey drink fortified with vitaminE | Experimental | consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week, Receives: Dietary Supplement: whey drink fortified with vitaminE |
| vitaminE | Experimental | consumption of 400 milligrams of vitamin E three times a week, Receives: Dietary Supplement: vitamin E |
| D- control | No intervention | control group: no intervention, |
What is being measured
The primary outcome is the main question the study is designed to answer.
malnutrition (based on SGA assessment)
Measured: 2 months (8 weeks)
Malnutrition inflammation score
Measured: 2 months (8 weeks)
Secondary outcomes (16)
serum interleukin-6
Measured: 2 months (8 weeks)
serum C-reactive protein
Measured: 2 months (8 weeks)
serum albumin
Measured: 2 months (8 weeks)
serum HDL-c
Measured: 2 months (8 weeks)
serum total cholesterol
Measured: 2 months (8 weeks)
serum triglyceride
Measured: 2 months (8 weeks)
serum transferrin
Measured: 2 months (8 weeks)
serum malondialdehyde
Measured: 2 months (8 weeks)
BUN (blood urea nitrogen)
Measured: 2 months (8 weeks)
serum creatinine
Measured: 2 months (8 weeks)
serum calcium
Measured: 2 months (8 weeks)
serum phosphate
Measured: 2 months (8 weeks)
quality of life
Measured: 2 months (8 weeks)
weight
Measured: 2 months (8 weeks)
height
Measured: 2 months (8 week)
Body mass index
Measured: 2 months (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad Hassan Eftekhari
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Responsible party
- Sponsor-investigator, Mohammad Hassan Eftekhari, Shiraz University of Medical Sciences
- Investigators
- Mohammad Hassan Eftekhari, professor, Study director, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163070
- Sponsor's protocol ID
- 91-6424
- Acronym
- EVEWD
- Status last verified
- Jan 2015
- First submitted
- 10 Jun 2014
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32390133
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin E Fortified Whey Drink on Nutritional Status, Inflammatory Markers and Oxidative Stress in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02163070
- Acronym / sponsor ID
- EVEWD / 91-6424
- Conditions
- Chronic Kidney Disease
- Keywords
- whey protein, malnutrition, oxidative stress, hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Mohammad Hassan EftekhariUniversity, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- consumption of 220 milliliters of whey drink three times a week,
- consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
- consumption of 400 milligrams of vitamin E three times a week,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| whey drink | Experimental | Dietary Supplement: whey drink,consumption of 220 milliliters of whey drink three times a week, |
| whey drink fortified with vitaminE | Experimental | Dietary Supplement: whey drink fortified with vitaminEconsumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week, |
| vitaminE | Experimental | Dietary Supplement: vitamin Econsumption of 400 milligrams of vitamin E three times a week, |
| D- control | No intervention | –control group: no intervention, |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- hospitalization in the last month;
- active infection;
- using immunosuppressant drugs or multi-vitamins;
- pregnancy, consuming whey or soy products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whey drink,consumption of 220 milliliters of whey drink three times a week, | Dietary supplement | whey drink |
| whey drink fortified with vitaminEconsumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week, | Dietary supplement | whey drink fortified with vitaminE |
| vitamin Econsumption of 400 milligrams of vitamin E three times a week, | Dietary supplement | vitaminE |
Primary outcome
malnutrition (based on SGA assessment)
Time frame: 2 months (8 weeks)
Malnutrition inflammation score
Time frame: 2 months (8 weeks)
16 secondary outcomes
serum interleukin-6
Time frame: 2 months (8 weeks)
serum C-reactive protein
Time frame: 2 months (8 weeks)
serum albumin
Time frame: 2 months (8 weeks)
serum HDL-c
Time frame: 2 months (8 weeks)
serum total cholesterol
Time frame: 2 months (8 weeks)
serum triglyceride
Time frame: 2 months (8 weeks)
serum transferrin
Time frame: 2 months (8 weeks)
serum malondialdehyde
Time frame: 2 months (8 weeks)
BUN (blood urea nitrogen)
Time frame: 2 months (8 weeks)
serum creatinine
Time frame: 2 months (8 weeks)
serum calcium
Time frame: 2 months (8 weeks)
serum phosphate
Time frame: 2 months (8 weeks)
quality of life
Time frame: 2 months (8 weeks)
weight
Time frame: 2 months (8 weeks)
height
Time frame: 2 months (8 week)
Body mass index
Time frame: 2 months (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- Derived from this study: PubMed 32390133Mah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Hassan Eftekhari, professor study director
Shiraz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing whey drink,, whey drink fortified with vitaminE and vitamin E in people with Chronic Kidney Disease, run by Mohammad Hassan Eftekhari.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
malnutrition (based on SGA assessment) (time frame: 2 months (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.