NCT07670611 VITAMIN D2 VERSUS VITAMIN D2 PLUS CALCITRIOL IN CHOLESTATIC CHILDREN WITH VITAMIN D DEFICIENCY
| NCT ID | NCT07670611 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chulalongkorn University |
| Condition | Cholestatic Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2026-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 54 participants in total. It began in 2026-04-28 with a primary completion date of 2026-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pre-existing hypercalciuria, screened by urine calcium testing before enrollment. * Patients with benign or malignant tumors. * Patients with renal tubular defects, screened by electrolyte testing before enrollment. * Patients currently receiving anticonvulsant therapy. * Patients who do not attend scheduled follow-up visits.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07670611 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Cholestatic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07670611 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07670611 currently recruiting?
Yes, NCT07670611 is actively recruiting participants. Contact the research team at namobnamob@docchula.com for enrollment information.
Where is the NCT07670611 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT07670611 clinical trial?
NCT07670611 is sponsored by Chulalongkorn University. The trial plans to enroll 54 participants.