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Идёт набор NCT07670611

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

Фаза IV С лечением Cholestatic Liver Disease Chronic Liver Disease (CLD) Vitamin D Deficiency Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Vitamin D2, Calcitriol.
Кому может быть актуально
Состояния в реестре: Cholestatic Liver Disease, Chronic Liver Disease (CLD), Vitamin D Deficiency, Children. Базовые параметры: до 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
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Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Таиланд · 1 центр
  • King Chulalongkorn Memorial Hospital — Bangkok

Идентификаторы

NCT: NCT07670611 · 0947/68

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗