Determining effect of educational - nutritional Interventions on micronutrients and phenylalanine in patients with phenylketonuria in Hamadan province
Design
Before & After Clinical Trial, with parallel groups
Settings and conduct
This study will be carried out at the Phenyl Ketronyuria Clinic of Besat Hospital in Hamadan. carers will be trained , and dietary foods for patients and instructions of diet will be provided for target group, The test will include phenylalanine and micronutrients will be performed before and after intervention in the province's reference laboratory .
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- A 1-12 year old child with phenyl ketoneuria;
- Active file of the patient's care;
- Informed consent of parents;
Exclusion criteria:
-Malignant phenylketonuria;
-Not receiving special diet;
Intervention groups
The study consists of two intervention groups.
One group will receive counseling and training for special diet and
the other group will receive free specialty foods for patients with phenylketonuria
The effect of educational - nutritional Interventions on micronutrients and Phenylalanine in patients with Phenylketonuria
Public title
The effect of educational - nutritional Interventions on micronutrients and phenylalanine in patients with phenylketonuria
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
A 12-12 year old child with phenylketoneuria
Active file of the patient's case under care
Informed consent of parents
Exclusion criteria:
Malignant phenylketonuria
Not receiving special diet
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
All patients with phenylketonuria 1-12 will be assigned into two groups through Simple randomization.
Randomized method: Simple randomization.
Randomized Unit: Individual.
Randomization Tool: Software.
Hiding: All participants in code study are assigned.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences,Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517659114
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.UMSHA.REC.1397.11
Health conditions studied
1
Description of health condition studied
Phenylketonuria
ICD-10 code
E70.0
ICD-10 code description
Classical phenylketonuria
Primary outcomes
1
Description
Blood phenylalanine
Timepoint
Before and after intervention
Method of measurement
Blood test
2
Description
Blood Vitamin D
Timepoint
Before and after intervention
Method of measurement
Blood test
3
Description
Blood Vitamin B12
Timepoint
Before and after intervention
Method of measurement
Blood test
4
Description
Blood zinc
Timepoint
Before and after intervention
Method of measurement
Blood test
5
Description
Blood hemoglobin
Timepoint
Before and after intervention
Method of measurement
Blood test
6
Description
Blood hematocrit
Timepoint
Before and after intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group receive counseling and training for special diet
Category
Behavior
2
Description
Intervention group: This group receive free specialty foods for patients with phenylketonuria
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Be'sat Hospital
Full name of responsible person
Mitra Javedan
Street address
Motahari Boulevard
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0033
Fax
+98 81 3265 1515
Email
mehrsam473@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences,Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517659114
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Reza Zamani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Hamadan University of Medical Sciences,Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517659114
Phone
+98 81 3424 5412
Fax
+98 81 3422 7978
Email
R.zamani@edu.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Zamani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Hamadan University of Medical Sciences,Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517659114
Phone
+98 81 3424 5412
Fax
+98 81 3422 7978
Email
R.zamani@edu.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Zamani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Hamadan University of Medical Sciences,Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517659114
Phone
+98 81 3422 5412
Fax
+98 81 3422 7978
Email
R.zamani@edu.umsha.ac.ir
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
Due to the use of data in future design studies, no plans have been devised to disseminate information.