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

Sponsor

Universitas Airlangga (Other)

Overall Status

Recruiting

CT.gov ID

NCT05333133

Collaborator

Danone Institute International (Other)

Enrollment

Location

Arm

14.9

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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

Hypothesis:

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

Condition or Disease	Intervention/Treatment	Phase
Failure to Thrive Infection, Bacterial Growth Faltering	Dietary Supplement: high calorie formula (oral nutritional supplement/ONS)	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pre-, post- intervention study designPre-, post- intervention study design

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 4, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High calorie formula on IGF-1, TNF-alpha and total lymphocyte counts Interventional study with pre-, post design after the subjects are diagnosed with TB and UTI, they will receive 400 ml (equal with 400 kcal) of high calorie formula per day, prescribed by the researcher (a pediatrician) for 90 days consumption. Body weight and body height will be monitored by the researcher group every 30 days to record the tolerance, acceptance and complaints (and the side effects) the blood will be withdraw at day 0 (before intervention) and day 90 (after intervention) to investigate the IGF-1, TNF-alpha and total lymphocyte counts	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 measure at day-0, day-14, day-30, day 60 and 90. Other Names: formula for special medical purposes

Arm

Intervention/Treatment

Experimental: High calorie formula on IGF-1, TNF-alpha and total lymphocyte counts

Interventional study with pre-, post design after the subjects are diagnosed with TB and UTI, they will receive 400 ml (equal with 400 kcal) of high calorie formula per day, prescribed by the researcher (a pediatrician) for 90 days consumption. Body weight and body height will be monitored by the researcher group every 30 days to record the tolerance, acceptance and complaints (and the side effects) the blood will be withdraw at day 0 (before intervention) and day 90 (after intervention) to investigate the IGF-1, TNF-alpha and total lymphocyte counts

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 measure at day-0, day-14, day-30, day 60 and 90.

Other Names:

formula for special medical purposes

Outcome Measures

Primary Outcome Measures

The effectiveness of high calorie formula on the subjects [90 days]
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
The effectiveness of high calorie formula on the subjects [90 days]
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
The effectiveness of high calorie formula on the subjects [day 0 pre intervention, day 91 post intervention]
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),
The effectiveness of high calorie formula on the subjects [90 days]
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.

Secondary Outcome Measures

The effectiveness of high calorie formula on the subjects [90 days]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children aged 1 years - 5 years with 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Husada Utama Hospital	Surabaya	East Java	Indonesia	60131

Sponsors and Collaborators

Universitas Airlangga
Danone Institute International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andy Darma, MD, Principal Investigator on Gastroenterology, Universitas Airlangga

ClinicalTrials.gov Identifier:

NCT05333133

Other Study ID Numbers:

IGF-1 in failure to thrive

First Posted:

Apr 18, 2022

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bacterial Infections

Failure to Thrive

Study Results

No Results Posted as of Apr 18, 2022