The Effect of Consumption of High calorie-Fruit Juice Fortified with Vitamin C on Protein Intake, Oxidative Stress and Amino Acid Profile of Children with Propionic Acidemia.
Determination of high-calorie vitamin C-fortified fruit juice intake on children with PA
Design
Two-arm, parallel group, single blind, randomized controlled trial (using number random table)
Settings and conduct
Research place: Emam Reza specialized and sub-specialized clinic
Following selection of qualified individuals, the complete study process will be explained to the parents and written informed consent will be obtained. Information will be collected by the researchers.
Participants will then be randomly assigned to intervention and control groups. Prior to starting the intervention, subjects in both groups will receive an individual low-protein diet for 7 days.
At the end of the week, parents will be asked to bring their children to the lab after a 2-4-hour fasting period. Blood samples will then be taken for serum separation and measurements of protein status-, oxidative stress-, and plasma amino acid profiles.
Fruit juices will be provided to the parents of both study groups.
At the end of the 12-week-intervention period, blood tests and anthropometric measurements will be repeated. To ensure the compliance, serum levels of vitamin C will be measured both at the beginning and endpoint of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children 2-6 years of age
Suffering from propionic acidemia (PA) according to metabolic panel test
Confirmation of the disease by genetic test (if possible)
Parental consent for participation in the study and daily intake of fruit juice Monthly cycles of one-week metronidazole therapy (10-20 mg/kg).
Exclusion criteria:
Parental dissent for participation in the study and daily intake of fruit juice
Intervention groups
Control group: receiving natural fruit juice
Intervention group: receiving natural high-calorie fruit juice fortified with vitamin C
Main outcome variables
Plasma amino acid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121019011168N3
Registration date:2018-08-19, 1397/05/28
Registration timing:registered_while_recruiting
Last update:2018-08-19, 1397/05/28
Update count:0
Registration date
2018-08-19, 1397/05/28
Registrant information
Name
Seyedeh Maryam Abdollahzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3649 1126
Email address
abdolahsm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Education, Shiraz University of Medical Sciences
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Consumption of High calorie-Fruit Juice Fortified with Vitamin C on Protein Intake, Oxidative Stress and Amino Acid Profile of Children with Propionic Acidemia.
Public title
The Effect of Consumption of High calorie-Fruit Juice Fortified with Vitamin C in the Management of Propionic Acidemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2-6 years of age
Suffering from propionic acidemia (PA) according to metabolic panel test
Confirmation of the disease by genetic test (if possible)
Parental consent for participation in the study and daily intake of fruit juice
Monthly cycles of one-week metronidazole therapy (10-20 mg/kg).
Exclusion criteria:
Parental dissent for participation in the study and daily intake of fruit juice
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly allocated into two groups of control and intervention using number random table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be blinded by the use of the same-shape package of fruit-juices to treatment allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of the Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.SUMS.REC.1396.135
Health conditions studied
1
Description of health condition studied
Propionic acidaemia
ICD-10 code
E71.1
ICD-10 code description
Other disorders of branched-chain amino-acid metabolism_Propionic acidaemia
Primary outcomes
1
Description
Amino acid profile
Timepoint
Before intervention, after intervention
Method of measurement
HPLC method
2
Description
Ammonia
Timepoint
Before intervention, after intervention
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Serum vitamin C
Timepoint
Before intervention, after intervention
Method of measurement
HPLC method
2
Description
Serum glutathione peroxidase
Timepoint
Before intervention, after intervention
Method of measurement
Enzymatic, colorimetric method
3
Description
Serum superoxide dismutase
Timepoint
Before intervention, after intervention
Method of measurement
Enzymatic, colorimetric method
4
Description
Total antioxidant capacity
Timepoint
Before intervention, after intervention
Method of measurement
Enzymatic, colorimetric method
5
Description
Serum total protein
Timepoint
Before intervention, after intervention
Method of measurement
Autoanalyzer, colorimetric method
6
Description
Serum Albumin
Timepoint
Before intervention, after intervention
Method of measurement
Autoanalyzer, colorimetric method
7
Description
Serum Prealbumin
Timepoint
Before intervention, after intervention
Method of measurement
Immunoturbidimetric method
Intervention groups
1
Description
Consumption of natural high calorie-fruit Juice fortified with vitamin C for 12 weeks; Intervention group
Category
Treatment - Other
2
Description
Consumption of natural fruit Juice for 12 weeks; Control group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Metabolic Clinic, Emam Reza specialized and sub-specialized clinic
Full name of responsible person
Seyedeh Maryam Abdollahzadeh, Ph.D. Candidate; Shiraz University of Medical Sciences
Street address
Emam Reza specialized and sub-specialized clinic, Namazi Sq.
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Mostafavipour (Vice Chancellor for Education, Shiraz University of Medical Sciences)
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3233 2093
Email
madopzsh@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
Seyedeh Maryam Abdolahzadeh
Position
Ph.D. Candidate of Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71645-111
Phone
+98 71 3725 1001
Fax
Email
abdolahsm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Mazloom
Position
Professor in Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71645-111
Phone
+98 71 3725 1001
Fax
Email
zohreh.mazloom@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Abdolahzadeh
Position
Ph.D. Candidate in Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71645-111
Phone
+98 71 3725 1001
Fax
Email
abdolahsm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no program for its release
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Report of the clinical study
When the data will become available and for how long
One year after finishing the data collection
To whom data/document is available
All researchers
Under which criteria data/document could be used
In order to complete research on the particular rare disease
From where data/document is obtainable
The corresponding author of the published article
What processes are involved for a request to access data/document
Sending an email to the corresponding author of the published article