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

NCT05333133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-06-22

No results posted yet for this study

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

Conditions

  • Failure to Thrive
  • Infection, Bacterial
  • Growth Faltering

Interventions

DIETARY_SUPPLEMENT

high calorie formula (oral nutritional supplement/ONS)

every subject is given 400 ml (equal with 400 kcal) high calorie formula for 90 days. before (day 0) and after (day 91) the intervention was enrolled, blood samples was taken to investigate IGF-1 and total lymphocyte counts. The body weight and body height will be measured at day-0, day-14, day-30, day 60 and 90.

Sponsors & Collaborators

  • Danone Institute International

    collaborator OTHER

  • Universitas Airlangga

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2022-06-30
Completion
2022-12-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05333133 on ClinicalTrials.gov