Cholestatic Liver DiseasePhase 4VITD-CHOLNCT07670611
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency
A Phase 4 study testing Vitamin D2 and Calcitriol in people with Cholestatic Liver Disease and Chronic Liver Disease (CLD), run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cholestatic Liver Disease, Chronic Liver Disease (CLD), Vitamin D Deficiency
- What is being tested?
- Vitamin D2 and Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- 28 Apr 2026to 20 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
King Chulalongkorn Memorial Hospital, 6622564493, research@chula.ac.th
About this study
Official title: Accelerated Correction of Vitamin D Deficiency in Cholestatic Children: a Comparative Trial of Vitamin D2 Monotherapy vs Combination Therapy With Calcitriol
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:
Read more
- 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
- Being tested
- Vitamin D2, Calcitriol
- Keywords
- cholestasis, pediatrics, vitamin d deficiency, Calcitriol, 25-Hydroxyvitamin D2
- Medical subject headings
- Vitamin D Deficiency, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Drug
Vitamin D2 40,000 IU/week weekly
CalcitriolDrug
Calcitriol 50 ng/kg/day once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin D2 |
| 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. Receives: Drug: Vitamin D2; Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 3
Secondary outcomes (14)
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.
Measured: Month 3
Number of Participants With Correction of Vitamin D Deficiency at Month 6
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start28 Apr 2026
- Primary completion10 Nov 2026 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholestatic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670611
- Sponsor's protocol ID
- 0947/68
- Acronym
- VITD-CHOL
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Correction of Vitamin D Deficiency in Cholestatic Children: a Comparative Trial of Vitamin D2 Monotherapy vs Combination Therapy With Calcitriol
- ClinicalTrials.gov ID
- NCT07670611
- Acronym / sponsor ID
- VITD-CHOL / 0947/68
- Keywords
- cholestasis, pediatrics, vitamin d deficiency, Calcitriol, 25-Hydroxyvitamin D2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D2 Monotherapy | Active comparator | Drug: Vitamin D2Participants 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 | Drug: Vitamin D2, Drug: CalcitriolParticipants 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2Vitamin D2 40,000 IU/week weekly | Drug | Vitamin D2 Monotherapy, Vitamin D2 Plus Calcitriol |
| CalcitriolCalcitriol 50 ng/kg/day once daily | Drug | Vitamin D2 Plus Calcitriol |
Primary outcome
Change From Baseline in Serum 25-Hydroxyvitamin D Concentration at Month 3
Time frame: Baseline and 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.
14 secondary outcomes
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
Change From Baseline in International Normalized Ratio at Month 3 and Month 6
Time frame: Baseline, Month 3, and Month 6
Change From Baseline in Serum Albumin Concentration at Month 3 and Month 6
Time frame: Baseline, Month 3, and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D2 and Calcitriol in people with Cholestatic Liver Disease and Chronic Liver Disease (CLD), run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact THANAPORN NiLYAEM (66852811244, namobnamob@docchula.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Serum 25-Hydroxyvitamin D Concentration at Month 3 (time frame: Baseline and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.