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

NCT01634698 | Completed DMC

• 1 other identifier: CEPHUCFF 06801
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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.

Study Arms (2)

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).

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).

Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia)

Interventions

retinyl palmitate (UNICEF, Melbourne, Australia) DIETARY_SUPPLEMENT

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

Also known as: vitamin A

RDR test (1500 UI vitamin A); RDR test (2500 IU vitamin A)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Gabriela Villaça Chaves

Rio de Janeiro, Rio de Janeiro, 22010050, Brazil

Location

Related Publications (1)

• 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.

  PMID: 21736776 RESULT

MeSH Terms

Conditions

Fibrosis

Interventions

retinol palmitate; United Nations; Vitamin A

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

International Agencies; Organizations; Health Care Economics and Organizations; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Gabriela V Chaves, PhD

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: July 6, 2012
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2008
• Last Updated: July 6, 2012

Record last verified: 2012-05

Locations

BR (1)