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

NCT07670611 | Recruiting Phase 4

• 1 other identifier: 0947/68
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Cholestatic Liver Disease; Chronic Liver Disease (CLD); Vitamin D Deficiency; Children

Keywords

cholestasis; pediatrics; vitamin d deficiency; Calcitriol; 25-Hydroxyvitamin D2

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Month 3

Secondary Outcomes (14)

• Number of Participants With Correction of Vitamin D Deficiency at Month 3

  Month 3

• Number of Participants With Correction of Vitamin D Deficiency at Month 6

  Month 6

• Change in Serum 25-Hydroxyvitamin D Level From Baseline to Month 6

  Baseline to Month 6

• Change From Baseline in Serum Parathyroid Hormone Concentration at Month 3 and Month 6

  Baseline, Month 3, and Month 6

• Change From Baseline in Serum 1,25-Dihydroxyvitamin D Concentration at Month 3 and Month 6

  baseline , Month 3, Month 6

Study Arms (2)

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.

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.

Drug: Vitamin D2; Drug: Calcitriol

Interventions

Vitamin D2 DRUG

Vitamin D2 40,000 IU/week weekly

Vitamin D2 Monotherapy; Vitamin D2 Plus Calcitriol

Calcitriol DRUG

Calcitriol 50 ng/kg/day once daily

Vitamin D2 Plus Calcitriol

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Cholestasis

Interventions

Ergocalciferols; Calcitriol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol

Central Study Contacts

THANAPORN NiLYAEM

CONTACT

66852811244; namobnamob@docchula.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: April 28, 2026
• Primary Completion: July 10, 2026
• Study Completion (Estimated): April 20, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)