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

NCT05333133 | Completed DMC

• 1 other identifier: IGF-1 in failure to thrive
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.to analyze the effect of high calorie formula on IGF-1 levels in children with failure to thrive
2. 2.to analyze the effect of high calorie formula on total lymphocyte counts with failure to thrive
3. 3.to analyze the effect of high calorie formula on TNF-alpha levels in children with failure to thrive
4. 4.there is significant increment of IGF-1 levels before and after the intervention
5. 5.there is significant difference of total lymphocyte counts before and after the intervention
6. 6.there is significant difference of TNF-alpha levels before and after the intervention

Conditions

Failure to Thrive; Infection, Bacterial; Growth Faltering

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• The effectiveness of high calorie formula on the subjects

  90 days

Study Arms (1)

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

EXPERIMENTAL

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)

Interventions

high calorie formula (oral nutritional supplement/ONS) 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.

Also known as: formula for special medical purposes

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

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Congenital Disease
• Congenital Heart Disease
• Edema
• Organomegaly
• Tumor
• Cerebral palsy and genetic syndromes
• Hormonal abnormality/disorders
• Drop out criteria:
• Lost contact

Sponsors & Collaborators

• Universitas Airlangga: lead
• Danone Institute International: collaborator

Study Sites (1)

Husada Utama Hospital

Surabaya, East Java, 60131, Indonesia

Location

MeSH Terms

Conditions

Failure to Thrive; Bacterial Infections

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator on Gastroenterology

Model Details: Pre-, post- intervention study design

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 18, 2022
• Study Start: October 4, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)