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

Ain Shams University

Status: Completed

Conditions: Chronic Liver Disease and Cirrhosis

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT05717569

vitaminD in liver diseases

Details and patient eligibility

About

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..

Full 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 .

Enrollment: 24 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Group A

Active Comparator group

Description:

Group A: Stoss vitamin D therapy

Treatment:

Drug: Vitamin D

Group B

Active Comparator group

Description:

Group B: Oral vitamin D therapy .

Treatment:

Drug: Vitamin D