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VITAMIN D2 VERSUS VITAMIN D2 PLUS CALCITRIOL IN CHOLESTATIC CHILDREN WITH VITAMIN D DEFICIENCY

ConditionsCholestatic Liver DiseaseChronic Liver Disease (CLD)Vitamin D DeficiencyChildren
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorChulalongkorn University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Vitamin D2

    Drug

    Vitamin D2 40,000 IU/week weekly

  • Calcitriol

    Drug

    Calcitriol 50 ng/kg/day once daily

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Vitamin D2 MonotherapyActive comparator 1 intervention
Group B: Vitamin D2 Plus CalcitriolExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Serum 25-Hydroxyvitamin D Level From Baseline to Month 3

Change in serum 25-hydroxyvitamin D (25-OHD) level, measured in ng/mL, from baseline to 3 months after treatment initiation. The change will be compared between participants receiving vitamin D2 monotherapy and those receiving vitamin D2 plus calcitriol.

Time frame
Baseline to Month 3

Secondary outcomes

1

Proportion of Participants With Correction of Vitamin D Deficiency at Month 3

Proportion of participants with serum 25-hydroxyvitamin D (25-OHD) level greater than or equal to 20 ng/mL at 3 months after treatment initiation.

Time frame
Month 3
2

Proportion of Participants With Correction of Vitamin D Deficiency at Month 6

Proportion of participants with serum 25-hydroxyvitamin D (25-OHD) level greater than or equal to 20 ng/mL at 6 months after treatment initiation.

Time frame
Month 6
3

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
4

Change in Serum Parathyroid Hormone Level

Baseline, Month 3, and Month 6

Time frame
Change in serum parathyroid hormone (PTH) level from baseline to Month 3 and Month 6.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov
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