Comparative Efficacy of Selected Vitamins (B9, B12, C, and D) on Cognitive Function in Parkinsons Disease.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 155
- 试验地点
- 1
研究概览
简要总结
Patients with Parkinsons disease are screened for eligibility based on diagnosis cognitive status MoCA less than 24 and medical exclusions including G6PD deficiency thalassemia liver or kidney disease ulcers and anemia Eligible participants provide informed consent and are assigned into five separate groups Group one receives standard care only Group two receives standard care with vitamin B9 Group three receives standard care with vitamin B12 Group four receives standard care with vitamin C Group five receives standard care with vitamin D
Baseline assessments include demographics vitals clinical history laboratory test such as Beta amyloid 40 and 42 ratio biomarker levels MoCA and Neuro QoL score scale Participants are monitored for adherence side effects and use of any additional medicines during the study
Follow up evaluations at baseline month three and month six include amyloid biomarker ratio cognitive function MoCA quality of life Neuro QoL and recording of adverse events After six months a final analysis is done to assess efficacy safety and improvement in quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Cognitive impairment (MoCA score below 24)receving standard PD therapy.
排除标准
- •Patients with Thalassemia Individual diagnosed with G6PD deficiency or Sickle cell disease Subject with Hemochromatosis (serum ferritin more than 1000ng/ml & transferrin saturation more than 45 percent Participants presenting with severe kidney disease or advanced renal/liver impairment (eGFR less than 30 ml/min/1.73m^2 , child pugh class C) History of gastric ulcers or pernicious anemia (vit B12 less than 150pg/ml) Case of severe anemia (HB less than 7g/dl).
研究者
S Safreen Rumana
SRM Institute of Science and Technology, Kattankulathur
