High Calorie Formula Intervention on Weight, Length Increment, Total Lymphocyte Counts, TNF-alpha and IGF-1 in Failure to Thrive Children

NCT ID: NCT05333133 Phase: NA Status: COMPLETED Enrollment: 80 Completion: 2022-12-30

Conditions

Failure to Thrive, Infection, Bacterial, Growth Faltering

Interventions

high calorie formula (oral nutritional supplement/ONS)

Summary

High calorie formula (Oral Nutrition Supplement/ONS) are products used for oral nutrition support with the aim to increase the nutritional intake. they are a nutrition treatment option children with limited intake. ONS are typically used in addition to a normal diet, when diet alone is insufficient to meet daily nutritional requirement due to infection or others. ONS should be treated like medication, ensure they are labelled with the patient's name and provided at the prescribed time.

It is well established that nutritional deficiency or inadequate can impair immune function. Growing evidence suggest that for certain conditions, the nutrient needs will be increased, so it is needed to provide the nutrient intake above currently recommended levels, in order to help optimizing the immune function, including improving the defense function and thus resistance to infection while maintaining tolerance.

Purposes:

1. to analyze the effect of high calorie formula on IGF-1 levels in children with failure to thrive
2. to analyze the effect of high calorie formula on total lymphocyte counts with failure to thrive
3. to analyze the effect of high calorie formula on TNF-alpha levels in children with failure to thrive

Hypothesis:

1. there is significant increment of IGF-1 levels before and after the intervention
2. there is significant difference of total lymphocyte counts before and after the intervention
3. there is significant difference of TNF-alpha levels before and after the intervention

Primary Outcome

The effectiveness of high calorie formula on the subjects

Source

ClinicalTrials.gov