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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• Patients younger than 18 years of age.

• Patients diagnosed with cholestasis, defined as direct/conjugated bilirubin \>1 mg/dL for more than 1 month.

• Patients diagnosed with chronic liver disease.

• Patients with vitamin D deficiency, defined as serum 25-hydroxyvitamin D (25-OHD) level \<20 ng/mL, according to the Endocrine Society Clinical Practice Guideline.

Locations
Other Locations
Thailand
King Chulalongkorn Memorial Hospital
RECRUITING
Bangkok
Contact Information
Primary
THANAPORN NiLYAEM
namobnamob@docchula.com
66852811244
Time Frame
Start Date: 2026-04-28
Estimated Completion Date: 2027-04-20
Participants
Target number of participants: 54
Treatments
Active_comparator: Vitamin D2 Monotherapy
Participants in this arm will receive vitamin D2 40,000 IU orally once weekly for 3 months. At month 3, participants whose 25-hydroxyvitamin D level remains below 20 ng/mL may receive treatment adjustment according to the study protocol.
Experimental: Vitamin D2 Plus Calcitriol
Participants in this arm will receive vitamin D2 40,000 IU orally once weekly plus calcitriol 50 ng/kg/day orally for 3 months. At month 3, participants whose 25-hydroxyvitamin D level remains below 20 ng/mL may receive treatment adjustment according to the study protocol.
Sponsors
Leads: Chulalongkorn University

This content was sourced from clinicaltrials.gov