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Recruiting NCT07670611

Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency

Phase IV Interventional Cholestatic Liver Disease Chronic Liver Disease (CLD) Vitamin D Deficiency Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D2, Calcitriol.
Who it may be relevant to
Registry conditions: Cholestatic Liver Disease, Chronic Liver Disease (CLD), Vitamin D Deficiency, Children. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Vitamin D2
    Vitamin D2 40,000 IU/week weekly
  • Drug Calcitriol
    Calcitriol 50 ng/kg/day once daily

Primary outcome measures

  • Change From Baseline in Serum 25-Hydroxyvitamin D Concentration at Month 3 [Time frame: Baseline and Month 3]
Secondary outcome measures (12)
  • Number of Participants With Correction of Vitamin D Deficiency at Month 3 [Time frame: Month 3]
  • Number of Participants With Correction of Vitamin D Deficiency at Month 6 [Time frame: Month 6]
  • Change in Serum 25-Hydroxyvitamin D Level From Baseline to Month 6 [Time frame: Baseline to Month 6]
  • Change From Baseline in Serum Parathyroid Hormone Concentration at Month 3 and Month 6 [Time frame: Baseline, Month 3, and Month 6]
  • Change From Baseline in Serum 1,25-Dihydroxyvitamin D Concentration at Month 3 and Month 6 [Time frame: baseline , Month 3, Month 6]
  • Number of Participants With Hypercalcemia During the 6-Month Study Period [Time frame: Baseline to Month 6]
  • Change From Baseline in Pediatric End-Stage Liver Disease Score at Month 3 and Month 6 [Time frame: Baseline, Month 3, and Month 6]
  • Change From Baseline in Serum Alanine Aminotransferase Concentration at Month 3 and Month 6 [Time frame: Baseline, Month 3, and Month 6]
  • Change From Baseline in Serum Aspartate Aminotransferase Concentration at Month 3 and Month 6 [Time frame: Baseline, Month 3, and Month 6]
  • Change From Baseline in Serum Alkaline Phosphatase Concentration at Month 3 and Month 6 [Time frame: Baseline, Month 3, and Month 6]
  • Change From Baseline in Serum Total Bilirubin Concentration at Month 3 and Month 6 [Time frame: Baseline, Month 3, and Month 6]
  • Change From Baseline in Serum Direct Bilirubin Concentration at Month 3 and Month 6 [Time frame: Baseline, Month 3, and Month 6]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • King Chulalongkorn Memorial Hospital — Bangkok

Identifiers

NCT: NCT07670611 · 0947/68

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗