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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:
Full description
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).
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150 participants in 2 patient groups, including a placebo group
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Purwita Wijaya Laksmi, MD; Siti Setiati, Prof, MD, PhD
Data sourced from clinicaltrials.gov
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