A Phase 4 interventional study of Vitamin D2 and Calcitriol in Cholestatic Liver Disease, Chronic Liver Disease (CLD) and Vitamin D Deficiency, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Chulalongkorn University · Phase 4, Interventional, and Treatment
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:
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:
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's planned enrollment of 54 is below the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Vitamin D2
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.
Drug: Vitamin D2 · Drug: Calcitriol
Vitamin D2 40,000 IU/week weekly
Calcitriol 50 ng/kg/day once daily
Change From Baseline in Serum 25-Hydroxyvitamin D Concentration at Month 3
Change from baseline in serum 25-hydroxyvitamin D \[25(OH)D\] concentration, measured in ng/mL, at 3 months after treatment initiation. The change will be calculated as the Month 3 value minus the baseline value and compared between treatment groups.
Time frame: Baseline and Month 3
Number of Participants With Correction of Vitamin D Deficiency at Month 3
Number and percentage of participants with serum 25-hydroxyvitamin D \[25(OH)D\] concentration greater than or equal to 20 ng/mL at Month 3.
Time frame: Month 3
Number of Participants With Correction of Vitamin D Deficiency at Month 6
Number and percentage of participants with serum 25-hydroxyvitamin D \[25(OH)D\] concentration greater than or equal to 20 ng/mL at Month 6.
Time frame: Month 6
Change in Serum 25-Hydroxyvitamin D Level From Baseline to Month 6
Change in serum 25-hydroxyvitamin D (25-OHD) level, measured in ng/mL, from baseline to 6 months after treatment initiation.
Time frame: Baseline to Month 6
Change From Baseline in Serum Parathyroid Hormone Concentration at Month 3 and Month 6
Change from baseline in serum parathyroid hormone concentration, measured in pg/mL, at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value.
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in Serum 1,25-Dihydroxyvitamin D Concentration at Month 3 and Month 6
Change from baseline in serum 1,25-dihydroxyvitamin D concentration, measured in pg/mL, at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value.
Time frame: baseline , Month 3, Month 6
Number of Participants With Hypercalcemia During the 6-Month Study Period
Number and percentage of participants who develop hypercalcemia during the 6-month study period. Hypercalcemia is defined as albumin-corrected serum calcium above the age-specific upper limit of normal according to the study laboratory reference range.
Time frame: Baseline to Month 6
Change From Baseline in Pediatric End-Stage Liver Disease Score at Month 3 and Month 6
Change from baseline in the Pediatric End-Stage Liver Disease (PELD) score at Month 3 and Month 6. The PELD score is calculated using serum bilirubin, international normalized ratio, serum albumin, age less than 1 year, and growth failure. The PELD score has no fixed absolute minimum or maximum possible value and may range from negative to positive values. Higher scores indicate more severe liver disease and a higher risk of short-term mortality/transplant priority.
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in Serum Alanine Aminotransferase Concentration at Month 3 and Month 6
Change from baseline in serum alanine aminotransferase (ALT) concentration, measured in U/L, at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value.
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in Serum Aspartate Aminotransferase Concentration at Month 3 and Month 6
Change from baseline in serum aspartate aminotransferase (AST) concentration, measured in U/L, at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value.
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in Serum Alkaline Phosphatase Concentration at Month 3 and Month 6
Change from baseline in serum alkaline phosphatase concentration, measured in U/L, at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value.
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in Serum Total Bilirubin Concentration at Month 3 and Month 6
Change from baseline in serum total bilirubin concentration, measured in mg/dL, at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value.
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in Serum Direct Bilirubin Concentration at Month 3 and Month 6
Change from baseline in serum direct bilirubin concentration, measured in mg/dL, at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value.
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in International Normalized Ratio at Month 3 and Month 6
Change from baseline in international normalized ratio (INR) at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value. Higher INR values indicate worse coagulation function.
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in Serum Albumin Concentration at Month 3 and Month 6
Change from baseline in Serum Albumin Concentration at Month 3 and Month 6. The change will be calculated as the follow-up value minus the baseline value. Lower serum albumin values indicate worse hepatic synthetic function.
Time frame: Baseline, Month 3, and Month 6
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
Of 36 non-industry phase 4 interventional studies under Vitamin D Deficiency, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 6 months is below that.
Counting every sponsor, half of 37 studies reached it within 18 months; a quarter within 8 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Calcitriol