Different Regimens of Vitamin D in Treatment of Children With Chronic Liver Disease
Primary Purpose
Chronic Liver Disease and Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Liver Disease and Cirrhosis focused on measuring vitamin D, 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.
Sites / Locations
- Ain shams university
- EL Demerdash Hospital ,Ain Shams university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Group A: Stoss vitamin D therapy
Group B: Oral vitamin D therapy .
Outcomes
Primary Outcome Measures
Vitamin D3 level after each regimen
Quantitative estimation of 25(OH)D level was done using enzyme-linked immunoassay (ELISA) before and after therapy will be done.
Secondary Outcome Measures
Assessment of liver fibrosis by fibroscan
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.
Full Information
NCT ID
NCT05717569
First Posted
November 18, 2022
Last Updated
February 4, 2023
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05717569
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease and Cirrhosis
Keywords
vitamin D, fibroscan
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A: Stoss vitamin D therapy
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B: Oral vitamin D therapy .
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Fibroscan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vitamin D3 level after each regimen
Description
Quantitative estimation of 25(OH)D level was done using enzyme-linked immunoassay (ELISA) before and after therapy will be done.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Assessment of liver fibrosis by fibroscan
Description
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.
Time Frame
six months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tawhida Abdel-Ghaffar, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Name
EL Demerdash Hospital ,Ain Shams university
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
20494470
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.
Results Reference
background
PubMed Identifier
21555257
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.
Results Reference
background
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Different Regimens of Vitamin D in Treatment of Children With Chronic Liver Disease
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