Clinical trial NCT02753582: The Effect of SOD Enzyme on Frailty and HRQOL Among Indonesian Pre-frail Elderly: A Double Blind Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pre-frail Elderly
Keywords: Elderly, pre-frail, SOD
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Elderly aged 60 years or more with pre-frail condition
* Patients with SOD enzyme deficiency
* Willing to participate

Exclusion Criteria:

* 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

Primary outcomes:
measure: Frailty status
timeFrame: 6 months (24 weeks)
Secondary outcomes:
measure: Health related quality of life
timeFrame: 6 months (24 weeks)
measure: Anti-oxidant serum status
timeFrame: 6 months (24 weeks)
measure: Morbidity
timeFrame: 6 months (24 weeks)
measure: Hospitalization
timeFrame: 6 months (24 weeks)
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National Hospital
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Siti Setiati, Prof, MD, PhD
role: STUDY_CHAIR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Purwita Wijaya Laksmi, MD
role: STUDY_DIRECTOR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Kuntjoro Harimurti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Rahmi Istanti, MARS
role: PRINCIPAL_INVESTIGATOR
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