Chronic Liver Disease and CirrhosisNCT05717569
Different Regimens of Vitamin D in Treatment of Children With Chronic Liver Disease
A study testing Vitamin D in people with Chronic Liver Disease and Cirrhosis, run by Ain Shams University at 2 sites in Egypt.
Trial 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.. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children below the age of 18 with chronic liver disease.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain shams university
Cairo, 11566
EL Demerdash Hospital ,Ain Shams university
Cairo, 11566
About this study
Official title: Stoss Therapy Versus Weekly Regimen of Vitamin D in Treatment of Children With Chronic Liver Disease
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..
Read the 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
- Being tested
- Vitamin D
- Keywords
- vitamin D, fibroscan
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Fibroscan
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A: Stoss vitamin D therapy Receives: Drug: Vitamin D |
| Group B | Active comparator | Group B: Oral vitamin D therapy . Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (1)
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 May 2022
- Primary completion18 Nov 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Saad Mahmoud Ahmed, Ain Shams University
- Investigators
- Tawhida Abdel-Ghaffar, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717569
- Sponsor's protocol ID
- vitaminD in liver diseases
- Status last verified
- Feb 2023
- First submitted
- 18 Nov 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20494470Gonzalez-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.
PubMed 21555257
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stoss Therapy Versus Weekly Regimen of Vitamin D in Treatment of Children With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05717569
- Acronym / sponsor ID
- vitaminD in liver diseases
- Conditions
- Chronic Liver Disease and Cirrhosis
- Keywords
- vitamin D, fibroscan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Vitamin DGroup A: Stoss vitamin D therapy |
| Group B | Active comparator | Drug: Vitamin DGroup B: Oral vitamin D therapy . |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children below the age of 18 with chronic liver disease.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Fibroscano 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. | Drug | Group A, Group B |
Primary outcome
Vitamin D3 level after each regimen
Time frame: six months
Quantitative estimation of 25(OH)D level was done using enzyme-linked immunoassay (ELISA) before and after therapy will be done.
1 secondary outcome
Assessment of liver fibrosis by fibroscan
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 20494470Ratziu 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.
- Background: PubMed 21555257Gonzalez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tawhida Abdel-Ghaffar, Professor study chair
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Chronic Liver Disease and Cirrhosis, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D3 level after each regimen (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717569, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.