NCT02753582

The Effect of SOD Enzyme on Frailty and HRQOL Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled Trial

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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: 1. SOD enzyme can improve frailty status and health related quality of life among Indonesian pre-frail elderly. 2. SOD enzyme can increase anti-oxidant serum status among Indonesian pre-frail elderly. 3. SOD enzyme can decrease morbidity among Indonesian pre-frail elderly. 4. SOD enzyme can decrease hospitalization events among Indonesian pre-frail elderly.

Detailed description

1. Study design: randomized double blind placebo controlled trial. 2. 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. 3. Study subject: elderly outpatient (aged 60 years old or more) with pre-frail status, who visit the clinic for medical consultation. 4. Data sampling: consecutive method. 5. Sample size: 150 subjects (75 control group, 75 intervention group). 6. 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. 7. 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).

Conditions

• Pre-frail Elderly

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SOD+Gliadin Capsule
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-02-01
• Completion: 2017-04-01
• First posted: 2016-04-28
• Last updated: 2016-05-30

Locations

1 site across 1 country: Indonesia