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

NCT02753582 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-05-30

No results posted yet for this study

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.

Conditions

  • Pre-frail Elderly

Interventions

DIETARY_SUPPLEMENT

SOD+Gliadin Capsule

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Siti Setiati, Prof, MD, PhD · Fakultas Kedokteran Universitas Indonesia

  • Purwita Wijaya Laksmi, MD · Fakultas Kedokteran Universitas Indonesia

  • Kuntjoro Harimurti, MD · Fakultas Kedokteran Universitas Indonesia

  • Rahmi Istanti, MARS · Fakultas Kedokteran Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-02-28
Completion
2017-04-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753582 on ClinicalTrials.gov