RecruitingPhase 4NCT07670611

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

Accelerated Correction of Vitamin D Deficiency in Cholestatic Children: a Comparative Trial of Vitamin D2 Monotherapy vs Combination Therapy With Calcitriol


Sponsor

Chulalongkorn University

Enrollment

54 participants

Start Date

Apr 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn whether adding calcitriol to vitamin D2 can improve vitamin D deficiency in children with cholestasis and chronic liver disease. Cholestasis is a condition in which bile flow is reduced, which can make it difficult for the body to absorb and process vitamin D. The study will also learn about the safety of using vitamin D2 together with calcitriol. The main questions it aims to answer are: * Does vitamin D2 plus calcitriol increase blood 25-hydroxyvitamin D (25-OHD) levels more than vitamin D2 alone after 3 months of treatment? * Does vitamin D2 plus calcitriol help more children reach an adequate vitamin D level by 3 and 6 months? * What medical problems, especially high calcium or high phosphorus levels, occur during treatment? Researchers will compare children who receive vitamin D2 alone with children who receive vitamin D2 plus calcitriol to see which treatment improves vitamin D levels more effectively and safely. Participants will: * Take vitamin D2 alone or vitamin D2 plus calcitriol as assigned by randomization * Visit the clinic for study assessments at the start of the study, at 3 months, and at 6 months * Have blood tests to measure vitamin D levels, calcium, phosphorus, parathyroid hormone, liver function, and other safety markers * Have their treatment reviewed at 3 months; participants whose vitamin D level remains low may have their treatment adjusted according to the study plan * Bring back medication packages so researchers can check how regularly the study medicines were taken


Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Calcitriol and a drug called Vitamin D2 for people with children, cholestatic liver disease, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVitamin D2

Vitamin D2 40,000 IU/week weekly

DRUGCalcitriol

Calcitriol 50 ng/kg/day once daily


Locations(1)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

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NCT07670611


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