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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05333133
Enrollment
80
Registered
2022-04-18
Start date
2021-10-04
Completion date
2022-12-30
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failure to Thrive, Growth Faltering, Infection, Bacterial

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.

Interventions

DIETARY_SUPPLEMENThigh 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

Danone Institute International
CollaboratorOTHER
Universitas Airlangga
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Pre-, post- intervention study design

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The effectiveness of high calorie formula on the subjects90 daysChange 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

Secondary

MeasureTime frameDescription
The effectiveness of high calorie formula on the subjects90 daysChange 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).

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026