Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 5
SponsorIndonesia University
About this trial
The goal of this clinical trial is to learn if a high-energy liquid diet improves the nutritional status of children with chronic cholestasis (a liver condition that blocks bile flow). Researchers want to see if this diet helps children who are malnourished.
The main questions the study aims to answer are:
* Does the liquid diet raise the level of prealbumin (a marker of nutrition) in the blood? * Does the liquid diet raise the level of Insulin-like Growth Factor-1 (IGF-1) (a hormone that helps growth) in the blood?
Participants will:
* Consume a high-energy liquid diet for 14 days. * Give blood samples at the start and at the end of the 2-week study. * Keep a daily record of what they eat and drink in a food diary. Researchers will compare the blood test results from the start and the end of the study to see if the liquid diet works to improve the children's prealbumin and IGF-1 levels. This study is important to help children with liver problems grow better and stay healthy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children under 5 years old
Diagnosed with chronic cholestasis and severe malnutrition
Parental/guardian informed consent
Willingness to use a nasogastric tube (NGT) if indicated
Disqualifiers
Comorbidities (heart failure, chronic kidney disease, HIV)
Severe acute infections (acute gastroenteritis, dengue fever, pneumonia)
Post-liver transplant
Post-Kasai portoenterostomy (jaundice-free)
Trial design
Design model
Single group
Treatments tested in this trial
Nutrition Therapy
Other interventionThe nutritional therapy provided consists of a liquid formula with BPOM approval number MD 250976001600096 for subjects under 1 year of age, and BPOM approval number ML 562409102696 for subjects over 1 year of age. Patients are also given micronutrients in the form of vitamins A, D, E, and K, as well as vitamin B1, folic acid, and zinc as needed.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Nutrition Therapy GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Prealbumin and IGF-1 levels
The difference in prealbumin and IGF-1 levels before and after 14 days of nutritional therapy
Time frame
15 daysSecondary outcomes
1
Gastrointestinal tolerance for bowel movement
Frequency of bowel movement per day and description of stool consistency (Bristol stool chart)
Time frame
14 days2
Mid upper arm circumference changes
Mid upper arm circumference changes is assessed using upper arm circumference measurements on the day of baseline and on the fifteenth day (after 14 days of nutritional intervention)
Time frame
15 days3
Height gain
Height gain is a change in height measured in centimetres with 1 decimal. The height gain is defined as the height on day 15 minus the height on day 0. Height on day 0 and day 15 will also be plotted on the WHO Growth Chart height-for-age z-score, and the change of height-for-age z-score will also be measured.
Time frame
15 days4
Other illness duration
Other illness duration refer to the duration of other illness (patient's illness unrelated to their primary illness) in days during the study.
Time frame
14 daysSponsors and contacts
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Source ClinicalTrials.gov