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

Infection, Bacterial Clinical Trial

Official title:

High Calorie Formula Intervention on Weight, Length, Total Lymphocyte Count, TNF-α and IGF-1 in Growth Faltering Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05333133
• Other study ID #: IGF-1 in failure to thrive
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2023
• Source: Universitas Airlangga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Interventional study with pre-, post-test design. After the subject were diagnosed with infection (tuberculosis/TB or urinary tract infection/ UTI, the diagnosed will be determined by a pediatrician/the researcher based on clinical examination and laboratory findings), they will receive 400 kcal/day (96 g/day divided 4 times consumption) of high calorie formula prescribed by the researcher (A pediatrician) for 90 days consumption (8640 g). the subject will monitored every 30 days for acceptance, tolerance, weight increment, length increment evaluation until the end of study (90 day intervention).

The blood will be withdrawn at day 0 (before invention) and day 90 (after intervention) to measure the levels of TNF-alpha, IGF-1 and total lymphocyte count. Total lymphocyte count (TLC) was measured based on the complete blood report (white blood cells x 1000 x % lymphocyte). The high calorie formula is given as much as 400 kcal/day for 90 days after the subject were diagnosed with tuberculosis (TB) or urinary tract infection (UTI), determine as day 1. Before the intervention (day 0) and after the intervention (day 90), the subjects were taken the blood by laboratory employee of the private hospital in Surabaya, Indonesia.

The statistical analysis including test of normality and homogeneity test, followed by paired sample T-test or Wilcoxon, depend on the normality and homogeneity test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• Children aged 1 years - 5 years, are diagnosed tuberculosis (TB) and urinary tract infection (UTI)

Exclusion Criteria:

• Congenital Disease

• Congenital Heart Disease

• Edema

• Organomegaly

• Tumor

• Cerebral palsy and genetic syndromes

• Hormonal abnormality/disorders

Drop out criteria:

• Lost contact

Related Conditions & MeSH terms

• Bacterial Infections
• Failure to Thrive
• Growth Faltering
• Infection, Bacterial

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Husada Utama Hospital	Surabaya	East Java

Sponsors (2)

Lead Sponsor	Collaborator
Universitas Airlangga	Danone Institute International

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effectiveness of high calorie formula on the subjects	Change on body weight. The data will be presented as mean +/- SD (standard deviation). The body weight will be measure with baby Scale Seca 354 (in grams) for subjects <24 months age, and using Seca electronic flat scale 813 (in grams) for subjects >24 months age	90 days
Primary	The effectiveness of high calorie formula on the subjects	Change on body height/length. The data will be presented as mean +/- SD (standard deviation). The body height/length will be measure with infantometer Seca 416 (in cm) for subject <24 months age, and using stadiometer Seca 213 (in cm) for subjects >24 months age	90 days
Primary	The effectiveness of high calorie formula on the subjects	Change on IGF-1 levels (in ng/ml) will be presented as mean +/- SD (standard deviation). IGF-1 levels will be measured using Human IGF-1 Elisa kit 96 T (BT LAB),	day 0 pre intervention, day 91 post intervention
Primary	The effectiveness of high calorie formula on the subjects	The change on total lymphocyte count (TLC) before and after intervention, the data will be presented as mean +/- SD (standard deviation). TLC will measure based on complete blood count (CBC), with formula WBC x 1000 x % lymhocyte, express as a decimal.	90 days
Secondary	The effectiveness of high calorie formula on the subjects	Change on TNF-alpha levels (in ng/ml) will be presented as as mean +/- SD (standard deviation). TNF-alpha will measure using Human TNF-alpha Elisa kit 96 T (BT LAB).	90 days