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IRCT20181111041611N5 IRCT 2022-10-06 Kermanshah University of Medical Sciences Evaluation of high-protein-high-calorie diet on the state of children's growth plate 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 2022-09-23 anticipated 99 Complete https://irct.ir/trial/65741 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 Growth retardation. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Mehnoosh Samadi
School of Nutrition and Food Sciences,Above Farabi Hospital,Iesar Square
kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3710 2009 mehnoosh_samadi@yahoo.com Kermanshah University of Medical Sciences scientific Mehnoosh Samadi
School of Nutrition and Food Sciences,Above Farabi Hospital,Iesar Square
kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3710 2009 mehnoosh_samadi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) 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 4 years 8 years Both Lack of endocrine disease E64.0 Sequelae of protein-energy malnutrition Treatment - Devices Treatment - Devices 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. 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. 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. Kermanshah University of Medical Sciences Approved 2022-09-05 Ethics Committee of Kermanshah University of Medical Sciences Building No. 2, Research Council of Kermanshah University of Medical Sciences (KUMS), Shahid Beheshti Boulevard, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)