The aim of the present study was to evaluate the effect of fructose on the hyperphosphatemia in hemodialysis patients. 30 hemodialysis patients were enrolled in before and after randomized clinical trial. This patient’s blood phosphate was above 5.5 mg/dl for three month. The inclusion criteria were age more than 18 years; Able to cooperation; Constant consumption of fruit and fructose containing foods; Tolerance to drug; Have passed more than six months from diagnosis of chronic renal failure and to be at 4,5 stages of disease. All Patients in the intervention group (n=30) received fructose for two month (15 gr fructose daily). Other biochemical factors that were evaluated before and after intervention were TG, LDL, HDL, PTH, Na, K, Ca, HG, WBC, and platelet. Patients did not complete study were excluded. Data were analyzed by using SPSS16 and paired T test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307272017N15
Registration date:2013-12-02, 1392/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-02, 1392/09/11
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical science
Expected recruitment start date
2013-10-02, 1392/07/10
Expected recruitment end date
2013-12-06, 1392/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fructose on hyperphosphatemia in hemodialysis patients
Public title
Fructose effect on phosphate absorption from the gastrointestinal tract
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: More than six months have passed from diagnosis of Chronic Renal Failure and to be at 4,5 stages of disease, >18 years old, Satisfaction and cooperation of patient, Constant consumption of fruit and fructose containing foods, Tolerance to drug and side effects.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Scinces
Street address
Golgasht street - Medical college
City
Tabriz
Postal code
5166614711
Approval date
2013-09-30, 1392/07/08
Ethics committee reference number
92101
Health conditions studied
1
Description of health condition studied
Chronic Kidney Failure
ICD-10 code
N18.4, N18
ICD-10 code description
Chronic Kidney Failure
Primary outcomes
1
Description
Phosphate
Timepoint
Before and two months after the begining of trial
Method of measurement
Laboratory and mgr/dl
Secondary outcomes
1
Description
Leucocytes
Timepoint
Before and two months after of beginning of trial
Method of measurement
Labratory and Numerical
2
Description
HDL
Timepoint
Before and two months after the beginning of trial
Method of measurement
Laboratory and mgr/dl
3
Description
Triglycerides
Timepoint
Before and two months after the beginning of trial
Method of measurement
Laboratory and mgr/dl
4
Description
Na
Timepoint
Before and two months after the beginning of trial
Method of measurement
Laboratory and mgr/dl
5
Description
Calcium
Timepoint
Before and two months after the beginning of trial
Method of measurement
Laboratory and mgr/dl
6
Description
K
Timepoint
Before and after two months of beginning of trial
Method of measurement
Laboratory and mgr/dl
7
Description
PTH
Timepoint
Before and after two months of beginning of trial
Method of measurement
Laboratory and by kit
8
Description
LDL
Timepoint
Before and after two months of beginning of trial
Method of measurement
Laboratory and mgr/dl
9
Description
Cholesterol
Timepoint
Before and after two months of beginning of trial
Method of measurement
Laboratory and mgr/dl
10
Description
Platelet
Timepoint
Before and after two months of beginning of trial
Method of measurement
Laboratory and Numerical
11
Description
Hemoglobin
Timepoint
Before and after two months of beginning of trial
Method of measurement
Laboratory and Numerical
Intervention groups
1
Description
Intervention group: 15 grams fructose daily for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz university of medical sciences
Full name of responsible person
Hamid Tayebikhosroshahi
Street address
Golgasht street - Emam reza hosbital - Hemodialysis department
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Golgasht street- Medical college
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Hamid Tayebikhosroshahi
Position
Nephrologist - Manager of hemodialysis department
Other areas of specialty/work
Street address
Golgasht street- Emam reza hospital - Hemodialysis department
City
Tabriz
Postal code
5166614711
Phone
+98 914 315 8784
Fax
Email
Drtayebikh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Hamid Tayebikhosroshahi
Position
Nephrologist
Other areas of specialty/work
Street address
Golgasht street- Emam reza hospital - Hemodialysis department
City
Tabriz
Postal code
5166614711
Phone
+98 914 315 8784
Fax
Email
Drtayebikh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Siamak Nooshirvani
Position
Medical student
Other areas of specialty/work
Street address
Golgasht street- Medical college
City
Tabriz
Postal code
Phone
+98 45 1551 7963
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)