Chronic Liver DiseaseNCT01634698
Relative-dose-response Test (RDR) Adaptation for Chronic Liver Disease
A study testing retinyl palmitate (UNICEF, Melbourne, Australia) in people with Chronic Liver Disease, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
The relative-dose-response test (RDR) is considered to be the most accurate method for evaluating vitamin A nutritional status (VANS) in patients suffering from liver disease, as it infers the reserves of the vitamin in the liver. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- retinyl palmitate (UNICEF, Melbourne, Australia)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Dec 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of liver cirrhosis of viral etiology, alcoholic or metabolic action
Who cannot join
- malabsorption syndromes
- moderate or severe infection
- diabetes mellitus using insulin renal, cardiac or respiratory
- therapeutic doses of vitamin A in the 6 months prior to data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Responsiveness of RDR Test to Assess Hepatic Vitamin A Stores in Chronic Liver Disease
The relative-dose-response test (RDR) is considered to be the most accurate method for evaluating vitamin A nutritional status (VANS) in patients suffering from liver disease, as it infers the reserves of the vitamin in the liver. However, for the RDR test to reflect VANS in patients suffering from chronic liver disease, factors inherent to the disease need to be considered, such as possible malabsorption, advanced age, a drop in synthesis and/or the release of retinol binding protein (RBP), which would result in an inadequate response to the RDR test. Thus, the objective of present study is to assess the adequacy of two different protocol for using the RDR test in patients with cirrhosis and cirrhosis-related hepatocellular carcinoma.
Methods: The sample group was comprised of 178 patients at Federal University of Rio de Janeiro University Hospital (111 men) with several etiologies of liver cirrhosis at different stages in the progression of the disease. They were sorted into two groups, according to the retinyl palmitate dosage (1500 IU or 2500 IU) received at T0 (blood sample taken following a 12-hour fast). Following supplementation, the investigators took further blood samples five and seven hours later (T5 and T7). The investigators assessed VANS via concentrations of serum retinol and RBP, as well as by way of the RDR test. The cutoff points the investigators used for denoting inadequacy in the indicators retinol and RDR were, respectively, < 1.05 µmol/L and ≥ 20%. To classify the degrees of severity of the disease the investigators used the criteria established by Child \& Pugh (1973).
- Conditions
- Chronic Liver Disease
- Being tested
- retinyl palmitate (UNICEF, Melbourne, Australia)
- Keywords
- chronic liver disease, cirrhosis, vitamin A, RDR test, retinol-binding protein
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retinyl palmitate (UNICEF, Melbourne, Australia)Dietary supplement
Also called vitamin A
the patients received an oral dose of 1500 IU or 2500 IU, once.
| Study group | Role | What they receive |
|---|---|---|
| RDR test (1500 UI vitamin A) | Experimental | 81 patients with several etiologies of liver cirrhosis at different stages in the progression of the disease received 1500 UI retinyl palmitate dosage at T0 (blood sample taken following a 12-hour fast). Following supplementation, we took further blood samples five and seven hours later (T5 and T7). Receives: Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia) |
| RDR test (2500 IU vitamin A) | Experimental | 81 patients with several etiologies of liver cirrhosis at different stages in the progression of the disease received 2500 UI retinyl palmitate dosage at T0 (blood sample taken following a 12-hour fast). Following supplementation, we took further blood samples five and seven hours later (T5 and T7). Receives: Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in retinol status (RDR test) at 5 and/or 7 hour after supplementation
Therapeutic response is evaluated by means of circulating serum retinol, 5 and 7 hours after the administration of vitamin A. The RDR was calculated by the following formula, using the values of serum retinol in the three times of blood collection (Loerch et al., 1979), expressed in percentages:
RDR (%) = [(A0-Ax) / Ax] x100 where A0 is the serum retinol at time 0 (fasting) and Ax is the serum retinol 5 or 7 h after administration of vitamin A. It was used as the RDR cutoff ≥ 20%, indicating indirect hepatic reserve inadequate
Measured: RDR will be calculated for the two intervention groups (1500 or 2500 IU vitamin A), for the two moments of blood sampling, 5 and 7 hours after supplementation.
Secondary outcomes (1)
serum retinol-binding protein (RBP)
Measured: RBP were analyzed at baseline, 5 and 7 hours after supplementation as a variable that explain the appropriate response or failure to respond to the RDR test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Villaca Chaves, PhD, Universidade Federal do Rio de Janeiro
- Investigators
- Gabriela V Chaves, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634698
- Sponsor's protocol ID
- CEPHUCFF 06801
- Status last verified
- May 2012
- First submitted
- 25 Jun 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peres WA, Chaves GV, Goncalves JC, Ramalho A, Coelho HS. Vitamin A deficiency in patients with hepatitis C virus-related chronic liver disease. Br J Nutr. 2011 Dec;106(11):1724-31. doi: 10.1017/S0007114511002145. Epub 2011 Jun 8.
PubMed 21736776
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness of RDR Test to Assess Hepatic Vitamin A Stores in Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT01634698
- Acronym / sponsor ID
- CEPHUCFF 06801
- Conditions
- Chronic Liver Disease
- Keywords
- chronic liver disease, cirrhosis, vitamin A, RDR test, retinol-binding protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Jul 2012 (estimated)
- 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 relative-dose-response test (RDR) is considered to be the most accurate method for evaluating vitamin A nutritional status (VANS) in patients suffering from liver disease, as it infers the reserves of the vitamin in the liver. However, for the RDR test to reflect VANS in patients suffering from chronic liver disease, factors inherent to the disease need to be considered, such as possible malabsorption, advanced age, a drop in synthesis and/or the release of retinol binding protein (RBP), which would result in an inadequate response to the RDR test. Thus, the objective of present study is to assess the adequacy of two different protocol for using the RDR test in patients with cirrhosis and cirrhosis-related hepatocellular carcinoma.
Methods: The sample group was comprised of 178 patients at Federal University of Rio de Janeiro University Hospital (111 men) with several etiologies of liver cirrhosis at different stages in the progression of the disease. They were sorted into two groups, according to the retinyl palmitate dosage (1500 IU or 2500 IU) received at T0 (blood sample taken following a 12-hour fast). Following supplementation, the investigators took further blood samples five and seven hours later (T5 and T7). The investigators assessed VANS via concentrations of serum retinol and RBP, as well as by way of the RDR test. The cutoff points the investigators used for denoting inadequacy in the indicators retinol and RDR were, respectively, < 1.05 µmol/L and ≥ 20%. To classify the degrees of severity of the disease the investigators used the criteria established by Child \& Pugh (1973).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDR test (1500 UI vitamin A) | Experimental | Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia)81 patients with several etiologies of liver cirrhosis at different stages in the progression of the disease received 1500 UI retinyl palmitate dosage at T0 (blood sample taken following a 12-hour fast). Following supplementation, we took further blood samples five and seven hours later (T5 and T7). |
| RDR test (2500 IU vitamin A) | Experimental | Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia)81 patients with several etiologies of liver cirrhosis at different stages in the progression of the disease received 2500 UI retinyl palmitate dosage at T0 (blood sample taken following a 12-hour fast). Following supplementation, we took further blood samples five and seven hours later (T5 and T7). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of liver cirrhosis of viral etiology, alcoholic or metabolic action
Key exclusion criteria (4 listed)
- malabsorption syndromes
- moderate or severe infection
- diabetes mellitus using insulin renal, cardiac or respiratory
- therapeutic doses of vitamin A in the 6 months prior to data collection
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 |
|---|---|---|
| retinyl palmitate (UNICEF, Melbourne, Australia)Also: vitamin Athe patients received an oral dose of 1500 IU or 2500 IU, once. | Dietary supplement | RDR test (1500 UI vitamin A), RDR test (2500 IU vitamin A) |
Primary outcome
Change from Baseline in retinol status (RDR test) at 5 and/or 7 hour after supplementation
Time frame: RDR will be calculated for the two intervention groups (1500 or 2500 IU vitamin A), for the two moments of blood sampling, 5 and 7 hours after supplementation.
Therapeutic response is evaluated by means of circulating serum retinol, 5 and 7 hours after the administration of vitamin A. The RDR was calculated by the following formula, using the values of serum retinol in the three times of blood collection (Loerch et al., 1979), expressed in percentages: RDR (%) = [(A0-Ax) / Ax] x100 where A0 is the serum retinol at time 0 (fasting) and Ax is the serum retinol 5 or 7 h after administration of vitamin A. It was used as the RDR cutoff ≥ 20%, indicating indirect hepatic reserve inadequate
1 secondary outcome
serum retinol-binding protein (RBP)
Time frame: RBP were analyzed at baseline, 5 and 7 hours after supplementation as a variable that explain the appropriate response or failure to respond to the RDR test.
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 6 Jul 2012.
- Results publication: PubMed 21736776Peres WA, Chaves GV, Goncalves JC, Ramalho A, Coelho HS. Vitamin A deficiency in patients with hepatitis C virus-related chronic liver disease. Br J Nutr. 2011 Dec;106(11):1724-31. doi: 10.1017/S0007114511002145. Epub 2011 Jun 8.
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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.
Gabriela V Chaves, PhD principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retinyl palmitate (UNICEF, Melbourne, Australia) in people with Chronic Liver Disease, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 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 6 Jul 2012. 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 Brazil. 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?
Change from Baseline in retinol status (RDR test) at 5 and/or 7 hour after supplementation (time frame: RDR will be calculated for the two intervention groups (1500 or 2500 IU vitamin A), for the two moments of blood sampling, 5 and 7 hours after supplementation.). 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 NCT01634698, which also lists 1 linked publication.
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 6 Jul 2012.