Protocol summary

Study aim
Effects of synbiotic dessert fortified with vitamin D and calcium on nutritional biomarkers, inflammation, oxidative stress, state of malnutrition and quality of life in hemodialysis patients, in order to reduce the complications of chemical drugs and improve their quality of life
Design
Randomized parallel clinical trial with two groups of control and intervention with a sample size of 42
Settings and conduct
Hemodialysis patients in Namazi and Shahid Faghihi hospital at shiraz. with satisfaction of patients and under the supervision of the doctor, the intervention begins for eight weeks. Patients do the blood test for the examination considerable biomarkers and also do the needful questionnaire before and after the intervention.Each patient will dissolve 50 gramme of ordinary dessert or 50 gramme of fortified dessert daily for eight weeks. patients and investigator are blind.
Participants/Inclusion and exclusion criteria
patients who are on dialysis more than 6 months, patients with KT/V > 1.2, patients who are vigilant and can-do and Who are on special regiment for dialysis patients and patients who did not have any changes in their recieved erythropoitin for a month can joined the study and the patients with diabetes, cancer, malignity and autoimmune diseases, who are sensitive to dairy products, who are grafted and still grafted kidney is in their body and patients with vitamin D level more than 70 will not remain in the study.
Intervention groups
Control group: 50 gramme of ordinary dessert daily for 8 weeks in addition to conventional medical treatment of hemodialysis patients Intervention group: 50 gramme of fortified dessert daily for 8 weeks in addition to conventional medical treatment of hemodialysis patients
Main outcome variables
Evaluation of nutritional indices, inflammation, oxidative stress, markers and liver enzyme, state of malnutrition and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100223003408N5
Registration date: 2019-04-06, 1398/01/17
Registration timing: retrospective

Last update: 2019-04-06, 1398/01/17
Update count: 0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Maryam Ekramzadeh
Name of organization / entity
Shiraz University of Medical Sciences, Nutrition Department
Country
Iran (Islamic Republic of)
Phone
+98 917 317 3891
Email address
ekramzadeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
2019-06-20, 1398/03/30
Scientific title
Effect of Synbiotic Dessert Fortified with Vitamin D and Calcium on Nutritional Indices, Inflammation, Oxidative stress, Malnutrition and Quality of Life in Hemodialysis Patients
Public title
Synbiotic Dessert Fortified with Vitamin D and Calcium in Hemodialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are on dialysis more than 6 months Patients with KT/V > 1.2 Patients who are vigilant and can-do Who are on special regiment for dialysis patients Patients who did not have any changes in their recieved erythropoitin for a month
Exclusion criteria:
Patients with diabetes, cancer, malignity and autoimmune diseases Patients who are sensitive to dairy products Patients who are grafted and grafted kidney is in their body Patients with vitamin D level more than 70
Age
From 20 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 42
Actual sample size reached: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization, Individual, Random allocation software, 11 randomization sequence in permuted blocks of size 4 In this study, the allocation of people to the two groups was done using permutational block method. In this method, T represents the person who receives the intervention, and C represents the person who is in the control group. Considering the quadruple block; we achieved TTCC , TCCT , CTTC , TCCT , CCTT , TCCT , TCTC , TCCT , CCTT , TCTC and TTCC . Then, using the randomization software and sealed envelopes we allocate each one to a patient respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind: Participants and the researcher responsible for gathering data are blind in this study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
معاونت پژوهشي دانشگاه علوم پزشكي شيراز
Street address
شيراز - خيابان زند - ساختمان مركزي دانشگاه علوم پزشكي شيراز
City
شیراز
Province
Fars
Postal code
71348-14336
Approval date
2018-08-15, 1397/05/24
Ethics committee reference number
IR.SUMS.REC.1397.327

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5, End stage kidney disease: on dialysis

Primary outcomes

1

Description
Malondialdehyde (MDA)
Timepoint
Before and 60 days after intervention
Method of measurement
Spectrophotometry

Secondary outcomes

1

Description
Malnutrition-inflammation score
Timepoint
Before and 60 days after intervention
Method of measurement
Questionnaire

2

Description
Subjective global assessment
Timepoint
Before and 60 days after intervention
Method of measurement
Questionnaire

3

Description
Quality of life
Timepoint
Before and 60 days after intervention
Method of measurement
Questionnaire

4

Description
Vitamin D
Timepoint
Before and 60 days after intervention
Method of measurement
ELISA

5

Description
Total antioxidant capacity
Timepoint
Before and 60 days after intervention
Method of measurement
ELISA

6

Description
hsCRP
Timepoint
Before and 60 days after intervention
Method of measurement
ELISA

7

Description
CBC
Timepoint
Before and 60 days after intervention
Method of measurement
Cell counter

8

Description
Sodium
Timepoint
Before and 60 days after intervention
Method of measurement
Autoanalyser

9

Description
Potasium
Timepoint
Before and 60 days after intervention
Method of measurement
Autoanalyser

10

Description
Phosphor
Timepoint
Before and 60 days after intervention
Method of measurement
Autoanalyser

11

Description
Calcium
Timepoint
Before and 60 days after intervention
Method of measurement
Autoanalyser

12

Description
Albumin
Timepoint
Before and 60 days after intervention
Method of measurement
Autoanalyser

13

Description
Cratinine
Timepoint
Before and 60 days after intervention
Method of measurement
Autoanalyser

14

Description
Urea
Timepoint
Before and 60 days after intervention
Method of measurement
Autoanalyser

15

Description
Ferritin
Timepoint
Before and 60 days after intervention
Method of measurement
ELISA

Intervention groups

1

Description
Intervention group: 50 gramme of fortified dessert per day for 2 months
Category
Treatment - Other

2

Description
Control group: 50 gramme of placebo dessert for 2 months
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid faghihi hospital of Shiraz
Full name of responsible person
Maryam Ekramzade
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
71876-56895
Phone
+98 71 3612 1000
Email
m_ekramzade@yahoo.com

2

Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Maryam Ekramzade
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
71876-56895
Phone
+98 71 3612 1000
Email
m_ekramzade@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholam Reza Hatam
Street address
Zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 2559
Email
Ekramzadeh@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ekramzade
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
m_ekramzade@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Ekramzadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
Ekramzadeh@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Azad
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Email
Farzane.azad1990@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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