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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D2 Monotherapy | Active Comparator | 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. |
|
| Vitamin D2 Plus Calcitriol | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D2 | Drug | Vitamin D2 40,000 IU/week weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3 |
| Number of Participants With Correction of Vitamin D Deficiency at Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| THANAPORN NiLYAEM | Contact | 66852811244 | namobnamob@docchula.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Recruiting | Bangkok | 10330 | Thailand |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2026 | Jun 22, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 5, 2026 | Jun 22, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Calcitriol | Drug | Calcitriol 50 ng/kg/day once daily |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Month 3, and Month 6 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |