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

NCT ID: NCT05333133

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2022-12-30

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:

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

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.

Conditions

Failure to Thrive; Infection, Bacterial; Growth Faltering

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

high calorie formula (oral nutritional supplement/ONS)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

formula for special medical purposes

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danone Institute International

OTHER

Sponsor Role: collaborator

Universitas Airlangga

OTHER

Sponsor Role: lead

Responsible Party

Andy Darma, MD

Principal Investigator on Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Husada Utama Hospital

Surabaya, East Java, Indonesia

Countries

Indonesia

Other Identifiers

IGF-1 in failure to thrive

Identifier Type: -

Identifier Source: org_study_id