Comparing Vitamin D2 Alone Versus Vitamin D2 Plus Calcitriol to Improve Vitamin D Levels in Children With Cholestatic and Chronic Liver Disease

What this Trial Is About

Researchers are evaluating whether adding calcitriol to vitamin D2 can better improve vitamin D deficiency in children with cholestasis and chronic liver disease. Cholestasis reduces bile flow, making vitamin D absorption difficult, and this study aims to compare vitamin D2 alone versus vitamin D2 plus calcitriol. The trial also assesses the safety of using both treatments together, particularly monitoring calcium and phosphorus levels. Children in the study will be randomly assigned to receive either vitamin D2 alone at 40,000 IU once weekly or vitamin D2 plus calcitriol at 50 ngkg daily, both for 3 months. At 3 months, if vitamin D levels remain low, treatment adjustments may be made as outlined in the study plan. The study follows participants for 6 months to observe vitamin D level improvements and treatment effects. Participants will visit the clinic at the start, 3 months, and 6 months for assessments including blood tests measuring vitamin D levels, calcium, phosphorus, parathyroid hormone, liver function, and safety markers. Medication adherence is monitored by reviewing returned medication packages. Researchers will measure changes in vitamin D and related blood markers over time and track any medical problems such as high calcium levels during the study period.

Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency