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临床试验/NCT01634698
NCT01634698已完成不适用

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

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2007年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
178
试验地点
2
主要终点
Change from Baseline in retinol status (RDR test) at 5 and/or 7 hour after supplementation

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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).

干预措施: retinyl palmitate (UNICEF, Melbourne, Australia) (Dietary Supplement)

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).

干预措施: retinyl palmitate (UNICEF, Melbourne, Australia) (Dietary Supplement)

结局指标

主要结局

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

时间窗: 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

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriela Villaca Chaves, PhD

PhD

Universidade Federal do Rio de Janeiro

研究点 (2)

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