Vitamin D2 with Calcitriol in kids with cholestasis and vitamin D deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial compares vitamin D2 alone to vitamin D2 plus calcitriol in children with cholestasis and chronic liver disease who are deficient in vitamin D. Participants are followed over several months to see which approach raises 25-hydroxyvitamin D levels more and whether adequate levels are reached at 3 and 6 months, while monitoring safety signals such as high calcium or phosphorus. The study will help determine if the combination is safer or more effective than vitamin D2 alone in this specific pediatric population.

Why it matters

Who can join: the full rules

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.

Where it's running

• King Chulalongkorn Memorial Hospital
  Bangkok, Thailand Recruiting

Study contacts

• Study coordinator: THANAPORN NiLYAEM
• Email: namobnamob@docchula.com
• Phone: 66852811244

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.