Evaluation of high-calorie-high-protein diet enriched with arginine food resource with calcium supplementation on anthropometric indices and growth plate status of 4-8 years old children with developmental disorders
Determining effect of high-protein-high-calorie diet enriched with arginine food sources along with calcium supplement on anthropometric indicators and growth plate status of 4-8 year old children with growth disorder
Design
This study is a single-blind clinical trial with a parallel design and an allocation ratio of 1:1:1.
Settings and conduct
This study will be conducted in a period of 12 weeks on 99 children aged 4-8 years with developmental disabilities in Mohammad Kermanshahi Hospital. After explaining the objectives of the research and obtaining informed consent, the subjects will be evaluated for their growth plate status and anthropometric indicators.The condition of the growth plate will be measured using radiography of the wrist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 4-8 years, BMI less than 3 percentile of BMI chart for age or height less than 3 percentile of WHO height chart for age. Exclusion criteria: being under special diets in the last 6 months, suffering from endocrine, liver, kidney, thyroid, celiac disease and taking steroid or hormonal drugs.
Intervention groups
The first intervention group: children who are underweight (less than the 3rd percentile of the WHO BMI chart for age) and short (less than the 3rd percentile of the WHO height chart for age) under a high-protein-high-calorie diet for 12 weeks. Second intervention group: underweight and short children under a high-protein-high-calorie diet enriched with arginine food sources including peanuts, walnuts, soybeans (8 grams each), at night and before bed and calcium supplements (in the amount of 1 tablespoon daily with lunch). Control group: children with normal height and weight.
Main outcome variables
Growth plate status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181111041611N5
Registration date:2022-10-06, 1401/07/14
Registration timing:registered_while_recruiting
Last update:2022-10-06, 1401/07/14
Update count:0
Registration date
2022-10-06, 1401/07/14
Registrant information
Name
Mehnoosh Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3710 2009
Email address
mehnoosh_samadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of high-calorie-high-protein diet enriched with arginine food resource with calcium supplementation on anthropometric indices and growth plate status of 4-8 years old children with developmental disorders
Public title
Evaluation of high-protein-high-calorie diet on the state of children's growth plate
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A BMI below the 3rd percentile of the WHO BMI chart for age
Height placement below the 3rd percentile of the WHO height-for-age chart
Exclusion criteria:
Lack of endocrine disease
Age
From 4 years old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: stratified randomization.
The participants of this study are selected from among children with developmental delay referred to pediatric endocrinologists, after obtaining the necessary criteria. The person in charge of the project will register the samples by attending the endocrinology and pediatric office, and then according to the random sequence determined by the statistical consultant, the samples will be allocated to the intervention groups. In this study, stratified randomization will be used to ensure the balance of the characteristics of the participants in each group in terms of basic characteristics, such as growth plate status and gender. Stratified randomization ensures that the number of participants receiving each intervention will be perfectly balanced in each stratum. In this method, the randomization of the first layer will be based on gender and the next layer will be based on the state of the growth plate. Then, to hide the randomization, the allocation of the participants will be done by a computer or a random number list of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Because the intervention is in the form of providing diet, in this study, the participants and nutritionists are aware of the assigned arm to the intervention group, but the outcome assessors and data analysts will be blinded to the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Approval date
2022-09-05, 1401/06/14
Ethics committee reference number
IR.KUMS.REC.1401.252
Health conditions studied
1
Description of health condition studied
Growth retardation
ICD-10 code
E64.0
ICD-10 code description
Sequelae of protein-energy malnutrition
Primary outcomes
1
Description
Growth plate status
Timepoint
Before the start of the study, 12 weeks after the start of the intervention
Method of measurement
X-ray of the wrist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:They will be subjected to a high-protein-high-calorie diet for 12 weeks. In this intervention, the amount of energy needed by each patient will be calculated based on the normal weight and age and the protein content of 18% of the total calories. And at the end, in order to ensure the implementation of the diet, parents are asked to record the food received by the child in the form of a 3-day food record (two regular days and one day off) at the beginning of the study and the 6th week and at the end of the study, and in the counseling sessions which will be formed every week for the purpose of follow-up and provide to the relevant official.
Category
Treatment - Devices
2
Description
Intervention group2:under a high-protein-high-calorie diet enriched with arginine food sources including peanuts, walnuts, soybeans (8 grams each), in the evening meal and before going to bed and calcium supplement (at the rate of 1 tablespoon daily with lunch) for 12 weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Karam Ahmadian
Street address
Gomrek Street, Kermanshah, Iran
City
کرمانشاه
Province
Kermanshah
Postal code
6714897767
Phone
+98 83 3823 0218
Email
shimamoradi21@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Building No. 2, Research Council Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran.
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 6892
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences,Above Farabi Hospital,Iesar Square
City
kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3710 2009
Email
mehnoosh_samadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehnoosh Samadi
Position
Professor, Associate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences,Above Farabi Hospital,Iesar Square
City
kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3710 2009
Email
mehnoosh_samadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negin Kamari
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Num 11, Atlasi 28, Maskan
City
kermanshah
Province
Kermanshah
Postal code
6715999477
Phone
0833426570
Email
kamari.negin72@gmail.com
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