NCT02773147Unknown2 期
Effect of Vitamin B Substitution on Plasma NFL and Neurocognitive Performance in HIV-infected Individuals With Increased Plasma Homocysteine
Göteborg University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Declining NFL or decreased rate of increase of NFL
研究概览
简要总结
The purpose of this study is to investigate if B vitamin substitution have effect on NFL (neurofilament light protein) plasma levels and neurocognitive performance in HIV-infected individuals with increased plasma homocysteine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ability to understand and give informed consent to participate.
- •HIV-1 infected with stable ART > 12 months
- •Plasma HIV-RNA < 50 copies/ml
- •Plasma homocysteine ≥ 12 μmol/L (subjects with < 12 μmol/L will be included in the analysis of secondary endpoint 3 (see 5.4).
- •Male or female, age 18 or older.
排除标准
- •Treatment with trimethoprim-sulfamethoxazole or methotrexate
- •Ongoing B6, B12 or folate substitution
- •Antiepileptic treatment
- •Small bowel or ventricular resection
- •Disturbed absorption in small bowel (Mb Crohn, untreated coeliac disease)
- •Ongoing neurological disease or severe psychiatric disease
- •Any malignant tumor in the history.
- •Severe ongoing infection or opportunistic infection
- •AUDIT > 7 for men and > 5 for women
- •MADRS > 20
- •Significant B12 or folate deficiency that indicate substitution (all subjects will be offered adequate substitution, they will be included in the analysis of secondary endpoint 3 (see 5.4)).
- •Pregnancy at screening visit, or planning pregnancy during study period is an exclusion criteria. (Not due to toxicity of Triobe, but to elevated risk of being prescribed B-vitamins outside of trial. If study object gets pregnant during study, she can continue the study but must be excluded if she starts treatment with other B-vitamin treatment than Triobe.)
研究组 & 干预措施
Triobe
Experimental
Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months.
干预措施: Cyanocobalamin (Drug)
Triobe
Experimental
Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months.
干预措施: Folate (Drug)
Triobe
Experimental
Cyanocobalamin 0,5 mg. Daily for 24 months. Folate 0,8 mg. Daily for 24 months. Pyridoxine 3,0 mg. Daily for 24 months.
干预措施: Pyridoxine (Drug)
结局指标
主要结局
Declining NFL or decreased rate of increase of NFL
时间窗: One year
次要结局
未报告次要终点
研究者
研究点 (1)
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