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

May 27, 2016 updated by: Siti Setiati, Indonesia University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo National Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
SOD+Gliadin capsule is given in a dosage of 250 mg twice a day, for 24 weeks.
Dietary supplement: SOD+Gliadin Capsule
Other Names:
  • GLISODin
Placebo Comparator: Placebo
Placebo capsule is given in a dosage of 250 mg twice a day, for 24 weeks.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty status
Time Frame: 6 months (24 weeks)
Measured by FI-40 item questionnaire.
6 months (24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: 6 months (24 weeks)
Measured by EQ5D questionnaire.
6 months (24 weeks)
Anti-oxidant serum status
Time Frame: 6 months (24 weeks)
Measured by erythrocyte antioxidant enzymes activity, i.e. superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX).
6 months (24 weeks)
Morbidity
Time Frame: 6 months (24 weeks)
Measured by Cumulative Illness Rating Score (CIRS).
6 months (24 weeks)
Hospitalization
Time Frame: 6 months (24 weeks)
Observed hospitalization event during the study
6 months (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Study Chair: Siti Setiati, Prof, MD, PhD, Fakultas Kedokteran Universitas Indonesia
  • Study Director: Purwita Wijaya Laksmi, MD, Fakultas Kedokteran Universitas Indonesia
  • Principal Investigator: Kuntjoro Harimurti, MD, Fakultas Kedokteran Universitas Indonesia
  • Principal Investigator: Rahmi Istanti, MARS, Fakultas Kedokteran Universitas Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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