Different Regimens of Vitamin D in Treatment of Children With Chronic Liver Disease

Not Applicable

Completed

• Conditions: Chronic Liver Disease and Cirrhosis
• Interventions: Drug: Vitamin D

• Registration Number: NCT05717569
• Lead Sponsor: Ain Shams University

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 .

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-11-18
• Study First Submitted: 2022-11-18
• Study Completion: 2023-01-01
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-04
• Last Update Submitted: 2023-02-04
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Vitamin D	Group B: Oral vitamin D therapy .
Group A	Vitamin D	Group A: Stoss vitamin D therapy

Primary Outcome Measures

Name	Time	Method
Vitamin D3 level after each regimen	six months	Quantitative estimation of 25(OH)D level was done using enzyme-linked immunoassay (ELISA) before and after therapy will be done.

Secondary Outcome Measures

Name	Time	Method
Assessment of liver fibrosis by fibroscan	six months	Fibroscan will be done for both groups before and after vitamin D therapy to assess the degree of fibrosis by using probes according to the patient's chest diameter and plotting the results on kilo pascal with the Metavir score. Thus assessment of the effect of vitamin D by both regimes on halting the progression of liver fibrosis if found.

Trial Locations

Locations (2)

Ain shams university; 🇪🇬 Cairo, Egypt

EL Demerdash Hospital ,Ain Shams university; 🇪🇬 Cairo, Egypt