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

Universidade Federal do Rio de Janeiro

Status: Completed

Conditions: Chronic Liver Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01634698

CEPHUCFF 06801

Details and patient eligibility

About

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).

Enrollment: 178 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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178 participants in 2 patient groups

RDR test (1500 UI vitamin A)

Experimental group

Description:

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).

Treatment:

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

RDR test (2500 IU vitamin A)

Experimental group

Description:

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).

Treatment:

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