NCT02753582Unknown4 期
The Effect of Superoxide Dismutase (SOD) Enzyme on Frailty and Health Related Quality of Life Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Frailty status
研究概览
简要总结
The primary objective is to determine the effect of SOD enzyme on frailty and health related quality of life among Indonesian pre-frail elderly.
The secondary objective is to determine the effect of SOD enzyme on anti-oxidant status, morbidity, and hospitalization among Indonesian pre-frail elderly.
The study hypothesis:
- SOD enzyme can improve frailty status and health related quality of life among Indonesian pre-frail elderly.
- SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly.
- SOD enzyme can decrease morbidity among Indonesian pre-frail elderly.
- SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.
详细描述
- Study design: randomized double blind placebo controlled trial.
- Location and time of study: Geriatric Outpatient Clinic and Internal Medicine Outpatient Clinic in Cipto Mangunkusumo National Hospital Jakarta. Study will be conducted on April 2016 to April 2017.
- Study subject: elderly outpatient (aged 60 years old or more) with pre-frail status, who visit the clinic for medical consultation.
- Data sampling: consecutive method.
- Sample size: 150 subjects (75 control group, 75 intervention group).
- Data collection: demographic data, frailty status, health related quality of life, anthropometric data, anti-oxidant serum status, hospitalization during intervention, morbidity, nutritional status, food intake, hand grip strength.
- Intervention: SOD+Gliadin in capsule with a dose of 250 mg twice a day for 24 weeks will be given to intervention group, while placebo group will be given placebo capsule (amylum).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly aged 60 years or more with pre-frail condition
- •Patients with SOD enzyme deficiency
- •Willing to participate
排除标准
- •Patients with cognitive function impairment (AMT score < 8)
- •Patients with depression (Geriatric depression scale score >= 10)
- •Patients with history of cirrhotic hepatic disease or severe hepatic disease
- •Patients with kidney function impairment
- •Patients with gluten allergy and derivative products
- •Patients consume other antioxidant and omega-3 supplement
结局指标
主要结局
Frailty status
时间窗: 6 months (24 weeks)
Measured by FI-40 item questionnaire.
次要结局
- Anti-oxidant serum status(6 months (24 weeks))
- Morbidity(6 months (24 weeks))
- Health related quality of life(6 months (24 weeks))
- Hospitalization(6 months (24 weeks))
研究者
Siti Setiati
Prof. MD, PhD
Indonesia University
研究点 (2)
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