Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy

May 1, 2026 updated by: dr. Tri Faranita, MKed(Ped), SpA, Indonesia University

Preliminary Study: Effect of Nutrition Therapy on Prealbumin and IGF-1 Level in Severe Malnutrition Under Five Years Old With Chronic Cholestasis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study evaluates the effect of nutritional therapy on prealbumin levels and insulin-like growth factor-1 (IGF-1) levels in malnourished children with chronic cholestasis aged 3-59 months (primary outcome) and diet tolerance, nutritional status, and medical condition (secondary outcomes).

Prealbumin and IGF-1 levels are measured as primary outcomes at baseline (day 0) and at day 15. Diet tolerance is assessed using the Bristol Stool Chart, a daily vomiting record throughout the 14-day intervention period, and allergic reactions. The frequency of defecation and consistency of each stool are documented. Allergic reactions are also monitored during the intervention period, including symptoms such as fever, erythematous rash, pruritus, and respiratory symptoms such as shortness of breath. The onset, duration, and severity of these symptoms are recorded.

Vomiting is evaluated as the number of episodes per day over the 14-day intervention period, and the volume of each episode is recorded. Only vomiting attributable to diet intolerance is included in the analysis, while episodes related to other causes, such as coughing or crying, are excluded.

Anthropometric parameters, including weight, height, mid-upper arm circumference, and other relevant measurements, are assessed on day 0, day 8, and day 15 to monitor changes in nutritional status.

Medical conditions during the study period are closely monitored, including underlying diseases, comorbidities, and intercurrent illnesses (e.g., respiratory or gastrointestinal infections). Clinical changes, hospitalizations, medication use, and any complications occurring during the intervention are recorded to evaluate their potential impact on nutritional status and study outcomes.

Nutritional therapy is administered as a liquid diet providing 130% of the recommended daily allowance (RDA), with macronutrient and micronutrient composition adjusted according to the 2019 ESPGHAN and 2021 Tessitore guidelines, over a 14-day intervention period. To ensure accurate nutritional intake, feeding is administered via a nasogastric tube, with gradual advancement of caloric intake until reaching 130% of RDA by day 4. Feeding is performed by parents or caregivers who are trained in proper administration techniques, feeding schedules, and hygiene practices. Monitoring of dietary adherence is conducted by daily food recall, instant messaging, and video call supervision during feeding sessions.

Protocol for nutritional therapy advancement is as follows:

  • Calorie requirement is calculated by multiplying ideal body weight with daily energy requirement (recommended dietary allowance, RDA).
  • Ideal body weight is defined as the median weight for actual height based on WHO growth charts (weight-for-height/length).
  • Height age is defined as the median age corresponding to the patient's actual height based on WHO growth charts (height/length-for-age).

  • The target energy intake is set at 130% of RDA according to height age, in line with ESPGHAN 2019 and Tessitore 2021 recommendations.

    1. On the first day: patients are provided with 44 to 140 more calories than their usual daily intake, based on the results of a food recall analysis. Nutritional therapy is administered as a liquid diet via a nasogastric tube, divided into 8 feeding sessions per day (every 3 hours).
    2. On the second day to fourth day: caloric intake is gradually increased until reaching 130% of RDA on the fourth day. The feeding regimen (volume and frequency) is adjusted according to patient tolerance.
    3. From fourth day to fourteenth day: the patient is maintained on full nutritional therapy at 130% of RDA. Monitoring of intake is conducted through daily food recall and communication via instant messaging/video calls.

Adjustments to feeding (volume, frequency, or rate) are made based on diet tolerance. If gastrointestinal intolerance or metabolic complications occur, nutritional therapy is modified according to clinical guidelines.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Faculty of Medicine, University of Indonesia, Jakarta, DKI Jakarta 10430
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Covered by national health insurance or other insurance

Exclusion Criteria:

  • Comorbidities (heart failure, chronic kidney disease, HIV)
  • Severe acute infections (acute gastroenteritis, dengue fever, pneumonia)
  • Post-liver transplant
  • Post-Kasai portoenterostomy (jaundice-free)
  • Currently exclusively breastfeeding
  • Use of steroids or NSAIDs within two weeks prior to the study.
  • Receiving a transfusion of whole blood, fresh frozen plasma, or platelets within one week prior to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition Therapy Group
Nutrition therapy
Other: Nutrition Therapy
The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prealbumin and IGF-1 levels
Time Frame: 15 days
The difference in prealbumin and IGF-1 levels before and after 14 days of nutritional therapy
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal tolerance for bowel movement
Time Frame: 14 days
Frequency of bowel movement per day and description of stool consistency (Bristol stool chart)
14 days
Gastrointestinal tolerance for vomit
Time Frame: 14 days
Frequency of vomit per day and volume of vomit
14 days
Mid upper arm circumference changes
Time Frame: 15 days
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)
15 days
Height gain
Time Frame: 15 days
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.
15 days
Other illness duration
Time Frame: 14 days
Other illness duration refer to the duration of other illness (patient's illness unrelated to their primary illness) in days during the study.
14 days
Prevalence of allergic reaction
Time Frame: 14 days
Prevalence of subjects whom seems to have allergic reactions (rashes on skin) after receiving nutritional therapy
14 days
Prevalence of vomiting
Time Frame: 14 days
Prevalence of participants experiencing vomiting after receiving nutrition therapy
14 days
Prevalence of diarrhea
Time Frame: 14 days
Prevalence of participants experiencing diarrhea after receiving nutritional therapy
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Tri Faranita, dr, Sp.A, Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-12-1945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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