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

NCT ID: NCT01634698

Last Updated: 2012-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-12-31

Brief 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. 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

Keywords

chronic liver disease; cirrhosis; vitamin A; RDR test; retinol-binding protein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

retinyl palmitate (UNICEF, Melbourne, Australia)

Intervention Type: DIETARY_SUPPLEMENT

the patients received an oral dose of 1500 IU or 2500 IU, once.

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).

Group Type: EXPERIMENTAL

retinyl palmitate (UNICEF, Melbourne, Australia)

Intervention Type: DIETARY_SUPPLEMENT

the patients received an oral dose of 1500 IU or 2500 IU, once.

Interventions

retinyl palmitate (UNICEF, Melbourne, Australia)

the patients received an oral dose of 1500 IU or 2500 IU, once.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

vitamin A

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Gabriela Villaca Chaves, PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriela V Chaves, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

Gabriela Villaça Chaves

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 21736776 (View on PubMed)

Other Identifiers

CEPHUCFF 06801

Identifier Type: -

Identifier Source: org_study_id