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

Sponsor

Universidade Federal do Rio de Janeiro (Other)

Overall Status

Completed

CT.gov ID

NCT01634698

Collaborator

(none)

178

Enrollment

Location

Arms

Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Liver Disease	Dietary Supplement: retinyl palmitate (UNICEF, Melbourne, Australia)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

178 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

Responsiveness of RDR Test to Assess Hepatic Vitamin A Stores in Chronic Liver Disease

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: vitamin A

Arm

Intervention/Treatment

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 Names:

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 Names:

vitamin A

Outcome Measures

Primary Outcome Measures

Change from Baseline in retinol status (RDR test) at 5 and/or 7 hour after supplementation [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

Secondary Outcome Measures

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.]