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Study aim
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To determine the therapeutic effect of pancreatic enzymes to increase the growth criteria of children with moderate and severe malnutrition
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Design
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A randomized controlled clinical trial with parallel group, single blind, phase 3 on 60 children. Randomization was done by SAS software.
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Settings and conduct
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17 shahrivar childrens' hospital, Rasht
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Participants/Inclusion and exclusion criteria
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All children aged 2 to 14 years with moderate and severe malnutrition who have a Z-score less than -2 will be included in the study. Patients who have type 3 growth disorder or type 2 growth disorder that hormonal problems have not been ruled out by an endocrinologist, or organic problems such as heart disease, lung disease, malabsorption disorder, exocrine pancreatic insufficiency, steatorrhea, and kidney disease are not included in the study.
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Intervention groups
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Intervention group: All 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. These children 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 undergo routine treatment the same as the intervention group.
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Main outcome variables
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Weight Gain: Weight is measured by a Seca scale (Germany) at the beginning and 2 months after.