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临床试验/NCT02433743
NCT02433743已完成不适用

Daily Consumption of Ready-to-use Peanut-based Therapeutic Food Increased Fat Free Mass, Improved Anemia Status But Has no Impact on Zinc Status of People Living With HIV/AIDS (PLWHA)

Cheikh Anta Diop University, Senegal1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Change from baseline in body composition at 9 weeks

研究概览

简要总结

A clinical trial was conducted in 65 PLWH randomly allocated to receive standard hospital diet alone (Control group: n=33), or the diet combined with 100 g/day of RUTF (RUTF group: n=32). Individual dietary intakes were measured and compared to the Recommended Dietary Allowances (RDA) for PLWH. Body composition was measured by bio-impedance analysis (BIA), hemoglobin by HemoCue and plasma zinc concentration by atomic absorption spectrometry and adjusted to infection (CRP and α1-AGP). All measures were conducted at baseline, 3 weeks and after 9 weeks home-based follow up.

详细描述

The sample size of the study (n=17 in each group) was calculated takin into account the mean gain of fat free mass (2.3± 2.1 kg) obtained in a study of PLWH supplemented with 43 g of RUTF/day. The randomization was performed upon admission using a computer-generated random number list (EPI INFO 6.0; Centers for Disease Control and Prevention, Atlanta).

Dietary intakes were measured during 7 consecutive days in 10 subjects of each group during the hospitalization period. Each meal served was weighed with a food scale (i-Balance 2600 Myweigh, Phoenix, USA).

Anthropometrics measurement was performed using standard procedures. Measure of height was made using height board (SECA 216, GmbH et Co, Hamburg, Germany), to the nearest millimeter. Body weight was measured with an electronic scale (SECA 877, GmbH & Co, Hamburg, Germany).

Body composition was measured using a multifrequency analyser, Xitron 4000B. The accuracy of the instrument was tested before the measurements by using a 422 ohm standard resistor purchased with the analyzer. Blood sampling was performed in the morning between 8 -10 AM into trace element-free polyethylene tubes zinc-free containing lithium heparin anticoagulant. The time of the sample collection and of the most recent food or milk intake were noted and used to adjust for this interval in the analysis of data. All the parameters were mesured in duplicate on admission, at 3 weeks and 9 weeks home based follup up.

Double entry data, and quality control of the entry were performed using Epi-Info version 3.5.1 (CDC, Atlanta, USA) and access. Statistical analysis was performed by Excel 2003 (Microsoft Corporation, Redmond, USA) and STATA / SE 11.0 (Stata Corporation, Texas, and USA). Results are expressed as mean ± standard deviation and percentage. PZ concentration was adjusted for the time interval between the last meal and the blood drawing to minimize the variability due to the known meal-related effects on PZ concentration and from infections/inflammation [28]. Zinc deficiency was defined according to IZINCG cut-off. ANOVA followed by post-hoc Bonferroni tests for pairwise comparison of means or Student's t-test were also used on dependent measures. The Pearson Chi2 test or Fisher's exact test were used to compare percentages. P values 0.05 were considered as significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •HIV/AIDS men and women
  • •at any WHO stages of HIV disease,
  • •under ART treatment or not,
  • •without psychiatric illness and not diabetic

排除标准

  • •confirmed HIV-negative,
  • •long term physical disability
  • •inability to eat

研究组 & 干预措施

Control

No Intervention

Control group (n=33) didn't received intervention. The received the standard hospital diet

Ready-to-use therapeutic food (RUTF)

Experimental

RUTF group (n=32) received the standard hospital diet combined with 100 g/day of RUTF

干预措施: Ready-to-use therapeutic food (RUTF) (Dietary Supplement)

结局指标

主要结局

Change from baseline in body composition at 9 weeks

时间窗: 9 weeks

Body composition was measured using Bio-impedance analysis method at baseline, and 9 weeks home-based follow-up in both supplemented and control groups

次要结局

  • Change from baseline on anemia at 3 weeks(3 weeks)
  • Change from baseline on plasma zinc concentration at 3 weeks(3 weeks)
  • Change from baseline on anemia at 9 weeks(9 weeks)
  • Change from baseline on plasma zinc concentration at 9 weeks(9 weeks)

研究者

发起方
Cheikh Anta Diop University, Senegal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean Louis Ndiaye

Adama Diouf

Cheikh Anta Diop University, Senegal

研究点 (1)

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