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

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.