InflammationNCT01874106
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
A study testing Diet Therapy in people with Inflammation and Malnutrition, run by Maryam Ekramzadeh, PhD at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate the effect of especial diet therapy "Anti-inflammatory Diet" on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(PEW) in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammation, Malnutrition, Protein Energy Wasting Syndrome
- What is being tested?
- Diet Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- Oct 2012to Aug 2013
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are on hemodialysis(HD) at least two times a week for 3months or more without any internment illness or admission
Who cannot join
- Hospitalization because of sepsis or surgery 3 months prior to intervention
- Cirrhosis
- Hepatitis virus infection
- Human Immunodeficiency virus infection
- Acquired Immunodeficiency Syndrome
- Active malignancy
Show all 18Show fewer
- Active infection
- Absence of communication
- Mental Impairment
- Terminal illness
- Tube feedings
- Total parenteral nutrition
- Pregnancy
- Not previously seen by a dietitian within 3 months prior to enrollment in the study
- Not expected to be transplanted within 6 months after the enrollment in the study
- Absence of malnutrition from a cause other than end stage renal disease(ESRD)
- Psychiatric conditions, preventing adherence to intervention
- Consuming immunosuppressive drugs or taking antioxidant supplements including Vitamin E, Vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid,Fish-oil extracts (omega-3 fatty acids), Soy extracts(isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts within 2 months prior to enrollment in the study
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shiraz University of Medical Sciences, Department of Nutrition
Shiraz, Fars
About this study
The purpose of this study is to evaluate the effect of especial diet therapy "Anti-inflammatory Diet" on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(PEW) in hemodialysis patients.
- Conditions
- Inflammation, Malnutrition, Protein Energy Wasting Syndrome, Oxidative Stress, Diet Therapy
- Being tested
- Diet Therapy, Control Group
- Keywords
- Hemodialysis, Diet, Inflammation, Malnutrition
- Medical subject headings
- Inflammation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet TherapyOther
The patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks.
Control GroupOther
The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Diet therapy | Experimental | The patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks. Receives: Other: Diet Therapy |
| Control Group | Other | The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum Albumin
Measured: 10 weeks
Secondary outcomes (14)
Change in Subjective Global Assessment (SGA) score
Measured: 10 weeks
Change in Malnutrition-inflammation score(MIS)
Measured: 10 weeks
Change in serum C-Reactive Protein(CRP)
Measured: 10 weeks
Change in serum malondialdehyde(MDA)
Measured: 10 weeks
Change in serum Interleukin-6(IL-6)
Measured: 10 weeks
Change in serum total antioxidant capacity(TAC)
Measured: 10 weeks
Change in serum ferritin
Measured: 10 weeks
Change in serum total iron binding capacity(TIBC)
Measured: 10 weeks
Change in serum urea nitrogen
Measured: 10 weeks
Change in serum creatinine
Measured: 10 weeks
Change in serum phosphorus
Measured: 10 weeks
Change in body fat mass index(BFMI)
Measured: 10 weeks
Change in fat free mass index(FFMI)
Measured: 10 weeks
Change in body cell mass(BCM)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maryam Ekramzadeh, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Responsible party
- Sponsor-investigator, Maryam Ekramzadeh, PhD, Shiraz University of Medical Sciences
- Investigators
- Zohreh Mazloom, PhD, Study director, Shiraz University of Medical Sciences, Faculty of NutritionMohammadmahdi Sagheb, MD, Study chair, Shiraz University of Medical Sciences, Nephrology Urology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874106
- Sponsor's protocol ID
- 916425
- Status last verified
- Jan 2014
- First submitted
- 6 Jun 2013
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01874106
- Acronym / sponsor ID
- 916425
- Conditions
- Inflammation, Malnutrition, Protein Energy Wasting Syndrome, Oxidative Stress, Diet Therapy
- Keywords
- Hemodialysis, Diet, Inflammation, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Maryam Ekramzadeh, PhDUniversity, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Jun 2013 (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 this study is to evaluate the effect of especial diet therapy "Anti-inflammatory Diet" on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(PEW) in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet therapy | Experimental | Other: Diet TherapyThe patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks. |
| Control Group | Other | Other: Control GroupThe patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are on hemodialysis(HD) at least two times a week for 3months or more without any internment illness or admission
Key exclusion criteria (18 listed)
- Hospitalization because of sepsis or surgery 3 months prior to intervention
- Cirrhosis
- Hepatitis virus infection
- Human Immunodeficiency virus infection
- Acquired Immunodeficiency Syndrome
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 |
|---|---|---|
| Diet TherapyThe patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks. | Other | Diet therapy |
| Control GroupThe patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks. | Other | Control Group |
Primary outcome
Change in serum Albumin
Time frame: 10 weeks
14 secondary outcomes
Change in Subjective Global Assessment (SGA) score
Time frame: 10 weeks
Change in Malnutrition-inflammation score(MIS)
Time frame: 10 weeks
Change in serum C-Reactive Protein(CRP)
Time frame: 10 weeks
Change in serum malondialdehyde(MDA)
Time frame: 10 weeks
Change in serum Interleukin-6(IL-6)
Time frame: 10 weeks
Change in serum total antioxidant capacity(TAC)
Time frame: 10 weeks
Change in serum ferritin
Time frame: 10 weeks
Change in serum total iron binding capacity(TIBC)
Time frame: 10 weeks
Change in serum urea nitrogen
Time frame: 10 weeks
Change in serum creatinine
Time frame: 10 weeks
Change in serum phosphorus
Time frame: 10 weeks
Change in body fat mass index(BFMI)
Time frame: 10 weeks
Change in fat free mass index(FFMI)
Time frame: 10 weeks
Change in body cell mass(BCM)
Time frame: 10 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 8 Jan 2014.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
Zohreh Mazloom, PhD study director
Shiraz University of Medical Sciences, Faculty of Nutrition
Mohammadmahdi Sagheb, MD study chair
Shiraz University of Medical Sciences, Nephrology Urology Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Therapy in people with Inflammation and Malnutrition, run by Maryam Ekramzadeh, PhD at 1 site in Iran.
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 1 inclusion and 18 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Change in serum Albumin (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2014.