CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT06160765
NCT06160765N/ACompleted

The Efficacy of High Density Formula1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children With Feeding Difficulties

Universitas Airlangga·observational·Posted Dec 7, 2023·Updated Jul 22, 2024

In Brief

An observational study for Growth Faltering and 2 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedDec 7, 2023
Enrollment StartNov 27, 2023
Primary CompletionMay 30, 2024
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.6 years ago