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

Pre-frail Elderly Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-frail Elderly

• NCT number: NCT02753582
• Study type: Interventional
• Source: Indonesia University
• Contact: Siti Setiati, Prof, MD, PhD
• Phone: 8138985588
• Email: s_setiati@yahoo.com
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2016
• Completion date: April 2017