Liver TransplantationNCT03592524
Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation
An observational study of Liver Transplantation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after liver transplantation (LT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Fasting Ramadan
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 17 May 2018to 21 Jun 2018
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: patients underwent Living donor liver transplantation
Who may be able to join
- • Recipients completed their first year after LDLT
- Normal liver and renal functions at least in the last 3 months before fasting
- No reported rejection episodes in the last 6 months before the study
- Recipients wishing to fast Ramadan
- Informed consent about the study
Who cannot join
- • First year of LDLT
- Recipients transplanted for Budd Chiari syndrome
- Recipients with vascular stents (hepatic artery , portal vein or hepatic vein stents) requiring long life anticoagulation
- Creatinine clearance <60 ml/min or serum creatinine >1.5 mg/dl at time of initial enrolment in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation: Single Center Study
The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after liver transplantation (LT).
Read the detailed description
Very limited data in the literature about how to apply Ramadan fasting in the post liver transplant setting. The timing of Ramadan is changeable according to the lunar year and according to time of down and sunset in each country. In Egypt, for example, Ramadan fasting this year started 17th of May and finished 14th June with average fasting hours of 15-16 hours The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after LT.This prospective study included 45 recipients who underwent LT at Ain Shams Center for Organ Transplant (ASCOT), Cairo, Egypt.
- Conditions
- Liver Transplantation
- Being tested
- Fasting Ramadan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting RamadanBehavioural
Muslims recipients refrain from eating and drinking anything from dawn until sunset(14-15 hours)
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of fasting on Allograft function among recipients post liver transplantation
Comparison between pre and post fasting state as regards allograft lfunctions , reflected by measuring AST, ALT(liver enzymes) , serum bilirubin , serum albumin +\_ liver biopsy if rejection is suspected
Measured: 1 month
Effect of fasting Ramadan on renal functions among recipients post liver transplantation
Comparison between fasting and post fasting renal functions ( serum creatinine, Blood urea nitrogen ,serum sodium and potassium
Measured: 1 month
Effect of Ramadan fasting on immunosuppressant trough level in liver transplantation recipients
Comparison between fasting and post fasting immunosuppressant drugs trough levels
Measured: 1 month
Secondary outcomes (2)
Effect of Ramadan fasting on blood pressure Among hypertensive recipients on antihypertensive drugs
For hypertension patients regular monitoring of blood pressure by sphingomanometer for any changes in these parameters on daily bases during the months
Measured: 1 month
Effect of fasting Ramadan on blood sugar control among diabetics recipients
Comparison between fasting and post fasting on blood sugar by daily measures of fasting and 2 hours postprandial blood sugar
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start17 May 2018
- Primary completion14 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592524
- Sponsor's protocol ID
- Ramadan fasting and liver
- Status last verified
- Jul 2018
- First submitted
- 22 Jun 2018
- Last updated
- 19 Jul 2018
- 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 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation: Single Center Study
- ClinicalTrials.gov ID
- NCT03592524
- Acronym / sponsor ID
- Ramadan fasting and liver
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 19 Jul 2018 (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 aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after liver transplantation (LT).
Detailed description
Very limited data in the literature about how to apply Ramadan fasting in the post liver transplant setting. The timing of Ramadan is changeable according to the lunar year and according to time of down and sunset in each country. In Egypt, for example, Ramadan fasting this year started 17th of May and finished 14th June with average fasting hours of 15-16 hours The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after LT.This prospective study included 45 recipients who underwent LT at Ain Shams Center for Organ Transplant (ASCOT), Cairo, Egypt.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients underwent Living donor liver transplantation
Key inclusion criteria (5 listed)
- • Recipients completed their first year after LDLT
Key exclusion criteria (4 listed)
- • First year of LDLT
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 |
|---|---|---|
| Fasting RamadanMuslims recipients refrain from eating and drinking anything from dawn until sunset(14-15 hours) | Behavioural | – |
Primary outcome
Effect of fasting on Allograft function among recipients post liver transplantation
Time frame: 1 month
Comparison between pre and post fasting state as regards allograft lfunctions , reflected by measuring AST, ALT(liver enzymes) , serum bilirubin , serum albumin +\_ liver biopsy if rejection is suspected
Effect of fasting Ramadan on renal functions among recipients post liver transplantation
Time frame: 1 month
Comparison between fasting and post fasting renal functions ( serum creatinine, Blood urea nitrogen ,serum sodium and potassium
Effect of Ramadan fasting on immunosuppressant trough level in liver transplantation recipients
Time frame: 1 month
Comparison between fasting and post fasting immunosuppressant drugs trough levels
2 secondary outcomes
Effect of Ramadan fasting on blood pressure Among hypertensive recipients on antihypertensive drugs
Time frame: 1 month
Effect of fasting Ramadan on blood sugar control among diabetics recipients
Time frame: 1 month
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 19 Jul 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Ain Shams University at 1 site 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 5 inclusion and 4 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Effect of fasting on Allograft function among recipients post liver transplantation (time frame: 1 month). The study lists 3 primary outcomes in all. 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 19 Jul 2018.