Failure to ThriveNCT05333133
High Calorie Formula Intervention on Weight, Length Increment, Total Lymphocyte Counts, TNF-alpha and IGF-1 in Failure to Thrive Children
A study testing high calorie formula (oral nutritional supplement/ONS) in people with Failure to Thrive and Infection, Bacterial, run by Universitas Airlangga at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Failure to Thrive, Infection, Bacterial, Growth Faltering
- What is being tested?
- high calorie formula (oral nutritional supplement/ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Oct 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 years - 5 years, are diagnosed tuberculosis (TB) and urinary tract infection (UTI)
Who cannot join
- Congenital Disease
- Congenital Heart Disease
- Edema
- Organomegaly
- Tumor
- Cerebral palsy and genetic syndromes
Show all 9Show fewer
- Hormonal abnormality/disorders
- Drop out criteria:
- Lost contact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Calorie Formula Intervention on Weight, Length, Total Lymphocyte Count, TNF-α and IGF-1 in Growth Faltering Children
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.
Read more
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
Read the 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
- Being tested
- high calorie formula (oral nutritional supplement/ONS)
- Medical subject headings
- Failure to Thrive, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high calorie formula (oral nutritional supplement/ONS)Dietary supplement
Also called formula for special medical purposes
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: high calorie formula (oral nutritional supplement/ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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),
Measured: 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.
Measured: 90 days
Secondary outcomes (1)
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).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start4 Oct 2021
- Primary completion30 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure to ThriveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-, post- intervention study design
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Institute International
- Responsible party
- Principal investigator, Andy Darma, MD, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333133
- Sponsor's protocol ID
- IGF-1 in failure to thrive
- Status last verified
- Jun 2023
- First submitted
- 25 Mar 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Calorie Formula Intervention on Weight, Length, Total Lymphocyte Count, TNF-α and IGF-1 in Growth Faltering Children
- ClinicalTrials.gov ID
- NCT05333133
- Acronym / sponsor ID
- IGF-1 in failure to thrive
- Conditions
- Failure to Thrive, Infection, Bacterial, Growth Faltering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Collaborators
- Danone Institute International
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-, post- intervention study design
| Arm | Type | Receives |
|---|---|---|
| High calorie formula on IGF-1, TNF-alpha and total lymphocyte counts | Experimental | Dietary Supplement: high calorie formula (oral nutritional supplement/ONS)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 |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 1 years - 5 years, are diagnosed tuberculosis (TB) and urinary tract infection (UTI)
Key exclusion criteria (9 listed)
- Congenital Disease
- Congenital Heart Disease
- Edema
- Organomegaly
- Tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high calorie formula (oral nutritional supplement/ONS)Also: formula for special medical purposesevery 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. | Dietary supplement | High calorie formula on IGF-1, TNF-alpha and total lymphocyte counts |
Primary outcome
The effectiveness of high calorie formula on the subjects
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
The effectiveness of high calorie formula on the subjects
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high calorie formula (oral nutritional supplement/ONS) in people with Failure to Thrive and Infection, Bacterial, run by Universitas Airlangga at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of high calorie formula on the subjects (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.