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IRCT20230313057703N1 IRCT 2023-06-18 Rasht University of Medical Sciences The effect of pancratic enzyme replacement therapy on anthropometric criteria in children with failure to thrive The effect of pancratic enzyme replacement therapy on anthropometric criteria in children with failure to thrive : A randomized controlled clinical trial 2023-06-22 anticipated 60 Complete https://irct.ir/trial/70432 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the treatment between the groups, the permutation randomization block method with size 4 will be used. Taking into account the time of the entry of people into the study and considering A (intervention group) and B (placebo group), a part of the random allocation will be in the following order: Randomization was done with SAS software version 9, Blinding description: Considering that the researcher and the patient may be aware of the type of intervention due to the difference in the prescribed drugs of the two groups, only the analyst will be blinded to the study. 3 Failure To Thrive in Child. Intervention 1: Intervention group: The intervention group received the following routine treatment: All the studied children received routine treatment in the form of daily zinc 0.3 mg/kg body weight unit, maximum 6 mg daily from zinc plus syrup (Eurovital brand) and elemental iron at the age of 2 -5 years 25 mg weekly and over 5 years 45 mg weekly of ferrous sulfate syrup (Abidi Company) and vitamin D 600 daily units of Vitamin D Ultra 1000 drops from the VitaBiotix brand, in addition to a specific nutritional program, which is in the form of a diet with increasing 300 to 500 calories are prescribed to the patients according to the condition of the patient under the supervision of a nutritionist. During the period of intervention, the patients are under the supervision of a gastroenterologist for 2 months, and the parents are asked to change their eating style. In addition, these people are treated for a two-month period with pancreatic enzymes (PERT) [Creon capsule (Abbott company) 25,000, which contains amylase 18,000, protease 1,000, and lipase 25,000] at the rate of 1,000 u/kg during 3 main meals (breakfast, lunch, dinner). Intervention 2: Control group: All studied children under routine treatment in the form of daily zinc 0.3 mg per kg of body weight unit maximum 6 mg daily from zinc plus syrup (Eurovital brand) and elemental iron at the ages of 2-5 years 25 mg weekly and over 5 years of age, 45 mg weekly of ferrous sulfate syrup (Abidi company) and vitamin D 600 daily units of Vitamin D Ultra 1000 drops from the VitaBiotix brand, in addition to a specific nutritional program, which is in the form of a diet with an increase of 300 to 500 calories according to the conditions. It was prescribed to the patients under the supervision of a nutritionist, and during the intervention period, the patients are followed up by a nutritionist for a period of 2 months, and they are under the supervision of a gastroenterology specialist, and parents are asked not to make any changes in the children's eating style. No - There is not a plan to make this available Justification or reason for not sharing IPD is regarding the ethical issues
public Shohreh Maleknejad
Namjoo street
Rasht Iran (Islamic Republic of) 4167811969 +98 13 3336 9002 maleknejadshohreh@yahoo.com Rasht University of Medical Sciences scientific Shohreh Maleknejad
Namjoo street
Rasht Iran (Islamic Republic of) 4167811969 +98 13 3336 9002 maleknejadshohreh@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) 2-14-year-old patients with failure to thrive whose Z-SCORE weight is below -2. 2 years 14 years Both type 3 failure to thrive Type 2 growth disorder that hormonal problems have not been ruled out by an endocrinologist. cardiovascular diseases pulmonary diseases malabsorption Pancreatic exocrine insufficiency steatorrhea renal diseases R62.8 Other lack of expected normal physiological development Treatment - Drugs Treatment - Drugs Intervention group: The intervention group received the following routine treatment: All the studied children received routine treatment in the form of daily zinc 0.3 mg/kg body weight unit, maximum 6 mg daily from zinc plus syrup (Eurovital brand) and elemental iron at the age of 2 -5 years 25 mg weekly and over 5 years 45 mg weekly of ferrous sulfate syrup (Abidi Company) and vitamin D 600 daily units of Vitamin D Ultra 1000 drops from the VitaBiotix brand, in addition to a specific nutritional program, which is in the form of a diet with increasing 300 to 500 calories are prescribed to the patients according to the condition of the patient under the supervision of a nutritionist. During the period of intervention, the patients are under the supervision of a gastroenterologist for 2 months, and the parents are asked to change their eating style. In addition, these people are treated for a two-month period with pancreatic enzymes (PERT) [Creon capsule (Abbott company) 25,000, which contains amylase 18,000, protease 1,000, and lipase 25,000] at the rate of 1,000 u/kg during 3 main meals (breakfast, lunch, dinner). Control group: All studied children under routine treatment in the form of daily zinc 0.3 mg per kg of body weight unit maximum 6 mg daily from zinc plus syrup (Eurovital brand) and elemental iron at the ages of 2-5 years 25 mg weekly and over 5 years of age, 45 mg weekly of ferrous sulfate syrup (Abidi company) and vitamin D 600 daily units of Vitamin D Ultra 1000 drops from the VitaBiotix brand, in addition to a specific nutritional program, which is in the form of a diet with an increase of 300 to 500 calories according to the conditions. It was prescribed to the patients under the supervision of a nutritionist, and during the intervention period, the patients are followed up by a nutritionist for a period of 2 months, and they are under the supervision of a gastroenterology specialist, and parents are asked not to make any changes in the children's eating style. Weight gain. Timepoint: At the beginning and 2 months after. Method of measurement: Weight is measured by a Seca scale (Germany) [this scale is calibrated every day], then the patients will be treated for 2 months and re-examined with the same scale. Height raise. Timepoint: at the beginning and 2 months after. Method of measurement: Height is measured by a tape measure from Seka (Germany), standing without shoes and attached to the wall at the beginning and 2 months after treatment. BMI raise. Timepoint: at the beginning and 2 months after. Method of measurement: BMI is calculated by dividing weight in kilograms by height in square meters. Z score raise. Timepoint: at the beginning and 2 months after. Method of measurement: By putting weight, height, and BMI in the Medscape calculator software, the Z SCORE number is reported. Rasht University of Medical Sciences Approved 2023-05-17 Guilan University of Medical Sciences siadati Rasht Guilan Iran (Islamic Republic of)