NCT05717569

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..

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

November 18, 2022

Last Update Submit

February 4, 2023

Conditions

Chronic Liver Disease and Cirrhosis

Keywords

vitamin Dfibroscan

Outcome Measures

Primary Outcomes (1)

  • 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.

    six months

Secondary Outcomes (1)

  • Assessment of liver fibrosis by fibroscan

    six months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A: Stoss vitamin D therapy

Drug: Vitamin D

Group B

ACTIVE COMPARATOR

Group B: Oral vitamin D therapy .

Drug: Vitamin D

Interventions

Vitamin DDRUG

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.

Also known as: Fibroscan
Group AGroup B

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children below the age of 18 with chronic liver disease.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain shams university

Cairo, 11566, Egypt

Location

EL Demerdash Hospital ,Ain Shams university

Cairo, 11566, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 20494470BACKGROUND

  • 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.

    PMID: 21555257BACKGROUND

MeSH Terms

Conditions

Fibrosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Tawhida Abdel-Ghaffar, Professor

    Ain Shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer of pediatrics ,Ain shams university

Study Record Dates

First Submitted

November 18, 2022

First Posted

February 8, 2023

Study Start

May 1, 2022

Primary Completion

November 18, 2022

Study Completion

January 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

EG(2)