Liver Transplant; ComplicationsPhase 1/2NCT05568836
Relationship Between Serum Vitamin D and Outcomes of Liver Transplantation in Cirrhotic Patients Undergoing Liver Transplantation and Effects of Vitamin D Supplementation in Post-transplant Period
A Phase 1/2 study testing vitamin D supplementation in people with Liver Transplant; Complications and Vitamin D Deficiency, run by National Nutrition and Food Technology Institute.
Trial summary
The study population is patients with liver cirrhosis undergoing liver transplantation; In this study, the sample will be selected from cirrhosis patients undergoing liver transplantation in Taleghani (Tehran), Imam Khomeini (Tehran) and Abu Ali Sina hospitals(Shiraz). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Transplant; Complications, Vitamin D Deficiency
- What is being tested?
- vitamin D supplementation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 10 Nov 2023
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ESLD underwent liver transplantation
- Creatinine, bilirubin and INR measured
- Measured liver enzymes such as serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase / or bilirubin
Who cannot join
- People with acute liver failure
- People who have had multiple organ transplants
- Primary graft non-function (PNF) individuals
Trial locations and contacts
No sites are listed yet.
About this study
The study population is patients with liver cirrhosis undergoing liver transplantation; In this study, the sample will be selected from cirrhosis patients undergoing liver transplantation in Taleghani (Tehran), Imam Khomeini (Tehran) and Abu Ali Sina hospitals(Shiraz).
This study uses the recorded information of patients with cirrhosis who have undergone liver transplantation so far and have inclusion criteria and no exclusion criteria. First, we extract demographic and clinical and pathophysiological information of patients, including age, sex, BMI, cause of cirrhosis, medical status at the time of liver transplantation, history of abdominal surgery, portal vein thrombosis, and waiting time for liver transplantation. In the next step, we examine the serum level of vitamin D in different age and sex groups and determine the prevalence of vitamin D deficiency for each group. It should be noted that in this study, the serum level of 25-hydroxy vitamin D below 20 ng/mL will be considered an insufficient level.
Read more
In the next step, in patients 12 years of age and older, according to serum bilirubin, serum creatinine, serum sodium and INR, we calculate the MELD-Na score and evaluate it with the serum level of vitamin D or 25-hydroxy vitamin D. We also use PELD scores in patients younger than 12 years of age, which consist of age, serum albumin, total bilirubin, INR, and stunted growth.
Follow-up will be done by calling the patients and recruitment every 3 month. ACR or acute cell rejection is usually suspected after elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin (30). The incidence of ACR and Overall survival (OS) will be considered as the end point of the first phase of the study, and finally the incidence of 25-hydroxy vitamin D before transplantation with MELD-Na or PELD score will be examined. ACR and OS, we deal with statistical tests.
In the second phase of the study, which is a clinical trial, 50 sample patients with vitamin D deficiency will be selected from Taleghani Hospital; After transplanting, we will inject 300,000 units of vit D IM and compare their ACR and OS levels with those who have been deficient in vitamin D but whose vitamin D status has not improved. It is worth mentioning that in the second phase of the study, patients will be followed up to 3 months after liver transplantation.
- Being tested
- vitamin D supplementation, control
- Keywords
- vitamin D, liver transplantation
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D supplementationDietary supplement
Intervention group will receive a single IM injection of 300000 IU vitamin D
controlOther
control group will receive nothing
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | single dose of 300000 IU vitamin D injection (IM) Receives: Dietary Supplement: vitamin D supplementation |
| Control | Other | No intervention Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR (acute cell rejection)
elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin
Measured: at the 3rd and 6th months after transplantation
Secondary outcomes (2)
MELD-Na or PELD score
Measured: at the 3rd and 6th months after transplantation
Serum vitamin D
Measured: at the 3rd and 6th months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion10 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568836
- Sponsor's protocol ID
- 31748
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Serum Vitamin D and Outcomes of Liver Transplantation in Cirrhotic Patients Undergoing Liver Transplantation and Effects of Vitamin D Supplementation in Post-transplant Period
- ClinicalTrials.gov ID
- NCT05568836
- Acronym / sponsor ID
- 31748
- Keywords
- vitamin D, liver transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 10 Nov 2023 (estimated)
- First posted
- 6 Oct 2022 (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 study population is patients with liver cirrhosis undergoing liver transplantation; In this study, the sample will be selected from cirrhosis patients undergoing liver transplantation in Taleghani (Tehran), Imam Khomeini (Tehran) and Abu Ali Sina hospitals(Shiraz).
This study uses the recorded information of patients with cirrhosis who have undergone liver transplantation so far and have inclusion criteria and no exclusion criteria. First, we extract demographic and clinical and pathophysiological information of patients, including age, sex, BMI, cause of cirrhosis, medical status at the time of liver transplantation, history of abdominal surgery, portal vein thrombosis, and waiting time for liver transplantation. In the next step, we examine the serum level of vitamin D in different age and sex groups and determine the prevalence of vitamin D deficiency for each group. It should be noted that in this study, the serum level of 25-hydroxy vitamin D below 20 ng/mL will be considered an insufficient level.
In the next step, in patients 12 years of age and older, according to serum bilirubin, serum creatinine, serum sodium and INR, we calculate the MELD-Na score and evaluate it with the serum level of vitamin D or 25-hydroxy vitamin D. We also use PELD scores in patients younger than 12 years of age, which consist of age, serum albumin, total bilirubin, INR, and stunted growth.
Follow-up will be done by calling the patients and recruitment every 3 month. ACR or acute cell rejection is usually suspected after elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin (30). The incidence of ACR and Overall survival (OS) will be considered as the end point of the first phase of the study, and finally the incidence of 25-hydroxy vitamin D before transplantation with MELD-Na or PELD score will be examined. ACR and OS, we deal with statistical tests.
In the second phase of the study, which is a clinical trial, 50 sample patients with vitamin D deficiency will be selected from Taleghani Hospital; After transplanting, we will inject 300,000 units of vit D IM and compare their ACR and OS levels with those who have been deficient in vitamin D but whose vitamin D status has not improved. It is worth mentioning that in the second phase of the study, patients will be followed up to 3 months after liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: vitamin D supplementationsingle dose of 300000 IU vitamin D injection (IM) |
| Control | Other | Other: controlNo intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ESLD underwent liver transplantation
- Creatinine, bilirubin and INR measured
- Measured liver enzymes such as serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase / or bilirubin
Key exclusion criteria (3 listed)
- People with acute liver failure
- People who have had multiple organ transplants
- Primary graft non-function (PNF) individuals
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 D supplementationIntervention group will receive a single IM injection of 300000 IU vitamin D | Dietary supplement | Intervention |
| controlcontrol group will receive nothing | Other | Control |
Primary outcome
ACR (acute cell rejection)
Time frame: at the 3rd and 6th months after transplantation
elevated liver enzymes (serum aminotransferases, alkaline phosphatase, gamma glutamyl transpeptidase) or bilirubin
2 secondary outcomes
MELD-Na or PELD score
Time frame: at the 3rd and 6th months after transplantation
Serum vitamin D
Time frame: at the 3rd and 6th months after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing vitamin D supplementation in people with Liver Transplant; Complications and Vitamin D Deficiency, run by National Nutrition and Food Technology Institute.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azita Hekmatdoost, MD, PhD (+98-22376470, a_hekmat2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR (acute cell rejection) (time frame: at the 3rd and 6th months after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.