Relative-dose-response Test (RDR) Adaptation for Chronic Liver Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gabriela Villaca Chaves, PhD, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01634698
First received: June 25, 2012
Last updated: July 2, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention
Chronic Liver Disease
Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Responsiveness of RDR Test to Assess Hepatic Vitamin A Stores in Chronic Liver Disease

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RDR test (1500 UI vitamin A)
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).
Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia)
the patients received an oral dose of 1500 IU or 2500 IU, once.
Other Name: vitamin A
Experimental: RDR test (2500 IU vitamin A)
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).
Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia)
the patients received an oral dose of 1500 IU or 2500 IU, once.
Other Name: vitamin A

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of liver cirrhosis of viral etiology, alcoholic or metabolic action

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01634698

Locations
Brazil
Gabriela Villaça Chaves
Rio de Janeiro, RJ, Brazil, 22010050
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Principal Investigator: Gabriela V Chaves, PhD Universidade Federal do Rio de Janeiro
  More Information

Publications:
Responsible Party: Gabriela Villaca Chaves, PhD, PhD, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01634698     History of Changes
Other Study ID Numbers: CEPHUCFF 06801
Study First Received: June 25, 2012
Last Updated: July 2, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
chronic liver disease
cirrhosis
vitamin A
RDR test
retinol-binding protein

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014