Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Effects of nutritional intervention on anthropometry in HIV infected individuals.
研究概览
简要总结
Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
详细描述
To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
A total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).
Participants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive individuals in the age range 18 to 50 years.
- •Individuals whose CD4 count was between 300-550 cells/uL.
- •Individuals who met the study criteria and were interested in being enrolled.
- •Individuals not on ARV therapy.
- •Women who were not pregnant.
排除标准
- •On the clinician's advice, individuals could be excluded from enrollment.
- •Individuals who were unable to carry out the study intervention e.g. homeless, impaired mental state etc.
- •Individuals who were unlikely to complete follow-up based on pre-enrolment assessment.
结局指标
主要结局
Effects of nutritional intervention on anthropometry in HIV infected individuals.
时间窗: 6 months
Body Mass Index
次要结局
- Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.(6 months)