CompletedNot Applicable

The Efficacy of High Density Formula 1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children

Indonesia150 participantsStarted 2023-11-27

Plain-language summary

High density calorie is an Oral Nutrition Supplement (ONS) which is a high calorie formula (High Density Formula) and suggested as nutritional therapy to assist children who are undernourished or undergoing growth faltering. The World Health Organization (WHO) and the Indonesian Ministry of Health have established regulations governing the use of ONS for children suffering from undernutrition, whether or not an infection is present. ONS available on the Indonesian market provides an energy density of between 1-1.5 kcal/ml. This study has the potential to clarify the advantages of ONS administration and evaluate its efficacy in comparison to nutritional therapy (1 kcal/ml or 1.5 kcal/ml) to facilitate rapid catch-up growth by examining the rate of increase in body weight, body lenght and undernourished children, particularly when infection is present. Purposes: 1. Analyze the effect of the 1.5 kcal/ml high dense formula (ONS) on the average weight gain in undernourished children accompanied by infections 2. Analyze the effect of the 1.5 kcal/ml calorie dense formula (ONS) on the average increase in PB in undernourished children accompanied by infections 3. Analyze the effect of the 1 kcal/ml calorie dense formula (ONS) on the average weight gain in undernourished children accompanied by infections 4. Analyze the effect of 1 kcal/ml calorie dense formula (ONS) on the average increase in PB in undernourished children accompanied by infections 5. Analyze the effect of the 1.5 kcal/ml calorie dense formula (ONS) on changes in nutritional status in undernourished children accompanied by infections

Who can participate

Age range

1 Year – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 1 years - 5 years, are diagnosed tuberculosis (TB) and urinary tract infection (UTI) * Children who have feeding difficulties * Children who malnourished or have undergoing weight malnutrition Exclusion Criteria: * Children with fluid retention * Children with organomegaly * Children with tumor masses. * Children with congenital abnormalities * Children wither cerebral palsy, hormonal disorders, and syndromes.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Body Weight

Timeframe: 3 months

Body Height

Timeframe: 3 months

Trial details

NCT IDNCT06160765

SponsorUniversitas Airlangga

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-30

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