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

NCT ID: NCT05717569

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-01-01

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 .

Conditions

Chronic Liver Disease and Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

Group A: Stoss vitamin D therapy

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

o 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 non-invasive 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 B

Group B: Oral vitamin D therapy .

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DRUG

o 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 non-invasive 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.

Interventions

Vitamin D

o 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 non-invasive 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.

Intervention Type: DRUG

Other Intervention Names

Fibroscan

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hebatallah Saad Mahmoud Ahmed

Assisstant lecturer of pediatrics ,Ain shams university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tawhida Abdel-Ghaffar, Professor

Role: STUDY_CHAIR

Ain Shams University

Locations

Ain shams university

Cairo, , Egypt

EL Demerdash Hospital ,Ain Shams university

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 20494470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21555257 (View on PubMed)

Other Identifiers

vitaminD in liver diseases

Identifier Type: -

Identifier Source: org_study_id