Clinical trial NCT05717569: Different Regimens of Vitamin D in Treatment of Children With Chronic Liver Disease
Official title: Stoss Therapy Versus Weekly Regimen of Vitamin D in Treatment of Children With Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease and Cirrhosis
Keywords: vitamin D
fibroscan
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 24
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim is to assess the efficacy of two different Vitamin D regimes in the treatment of vitamin D deficiency in children with chronic liver disease. The secondary aim is to evaluate the effect of vitamin D on liver fibrosis utilizing fibroscan..

Detailed description: • In this study, the investigators are going to find out the optimum regimen to be used for effective treatment of vitamin D deficiency in those patients and to study the effect of vitamin D treatment on liver fibrosis.

Vitamin D is a hormone involved in the regulation of mineral homeostasis. It protects skeletal integrity and modulates cell growth and differentiation . It is lipid soluble in nature and interacts with vitamin D receptors and regulates the expression of more than 200 genes, mostly involved in apoptosis, cell growth, and cell differentiation .

Fibroscan: as a non-invasive imaging study for measuring liver cirrhosis by transducer probe-induced elastic share wave that propagates through liver tissue to measure its velocity. It is a promising noninvasive method for detection of cirrhosis in patients with chronic liver disease. Therefore, fibroscan can be used regarding the decision of treatment and follow-up of patients with cirrhosis for screening and detection of the complications . In our study the investigators will assess liver fibrosis before and after vitamin D therapy using fibroscan.

Group A: who received stoss parenteral vitamin D therapy (200.000 IU) once followed by 600 IU/ day orally (equivalent to RDA as maintenance).

Group B: who received 50.000 IU/ week vitamin D orally for four weeks followed by the maintenance dose.

The total duration of therapy was 6 months in both groups .

Eligibility criteria: Inclusion Criteria:

Children below the age of 18 with chronic liver disease.

Exclusion Criteria:

* Patients with concomitant renal affection.
* Patients who are on anticonvulsant therapy.
* Patients who lost follow up
* Patients refuse to participate at any time throughout the study period.
* Non-compliant patients for more than 50% of time.

Primary outcomes:
measure: Vitamin D3 level after each regimen
timeFrame: six months
Secondary outcomes:
measure: Assessment of liver fibrosis by fibroscan
timeFrame: six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
city: Cairo
country: Egypt
facility: EL Demerdash Hospital ,Ain Shams university
Study officials:
affiliation: Ain Shams University
name: Tawhida Abdel-Ghaffar, Professor
role: STUDY_CHAIR
References:
citation: Ratziu V, Bellentani S, Cortez-Pinto H, Day C, Marchesini G. A position statement on NAFLD/NASH based on the EASL 2009 special conference. J Hepatol. 2010 Aug;53(2):372-84. doi: 10.1016/j.jhep.2010.04.008. Epub 2010 May 7. No abstract available.
citation: Gonzalez-Padilla E, Soria Lopez A, Gonzalez-Rodriguez E, Garcia-Santana S, Mirallave-Pescador A, Groba Marco Mdel V, Saavedra P, Quesada Gomez JM, Sosa Henriquez M. [High prevalence of hypovitaminosis D in medical students in Gran Canaria, Canary Islands (Spain)]. Endocrinol Nutr. 2011 Jun-Jul;58(6):267-73. doi: 10.1016/j.endonu.2011.03.002. Epub 2011 May 8. Spanish.